Trial Outcomes & Findings for The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma (NCT NCT00554515)
NCT ID: NCT00554515
Last Updated: 2024-08-28
Results Overview
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.
COMPLETED
PHASE2
123 participants
Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).
2024-08-28
Participant Flow
Participants enrolled from 13 institutions between November 2006 and November 2008.
Participant milestones
| Measure |
HD IL2
Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
|
|---|---|
|
Overall Study
STARTED
|
123
|
|
Overall Study
Treated
|
120
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
118
|
Reasons for withdrawal
| Measure |
HD IL2
Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Disease progression
|
52
|
|
Overall Study
Physician Decision
|
18
|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Death
|
2
|
|
Overall Study
Achieved Stable Disease
|
7
|
|
Overall Study
Other
|
1
|
|
Overall Study
Misc
|
15
|
Baseline Characteristics
The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
HD IL2
n=120 Participants
Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
|
MSKCC Risk Group
Favorable
|
23 Participants
n=5 Participants
|
|
MSKCC Risk Group
Intermediate
|
84 Participants
n=5 Participants
|
|
MSKCC Risk Group
Poor
|
13 Participants
n=5 Participants
|
|
UCLA SANI Score
Low
|
10 Participants
n=5 Participants
|
|
UCLA SANI Score
Intermediate
|
102 Participants
n=5 Participants
|
|
UCLA SANI Score
High
|
8 Participants
n=5 Participants
|
|
ISM Risk Group
Good
|
74 Participants
n=5 Participants
|
|
ISM Risk Group
Poor
|
43 Participants
n=5 Participants
|
|
ISM Risk Group
Unknown
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM good risk.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=74 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response in ISM Good Risk Group
|
.23 proportion of participants
Interval 0.14 to 0.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM poor risk.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on treatment on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=43 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate in ISM Poor Risk Group
|
.23 proportion of participants
Interval 0.14 to 0.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=120 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate (Independent Assessment)
|
.25 proportion of participants
Interval 0.175 to 0.337
|
—
|
—
|
SECONDARY outcome
Timeframe: Participants were followed for survival up to 7 years.Population: The analysis dataset is comprised of all treated patients.
Overall survival based on the Kaplan-Meier method is defined as the time from treatment start to date of death or censored at the date of last documented contact.
Outcome measures
| Measure |
ISM Good Risk Group
n=120 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Overall Survival
|
42.8 months
Interval 35.6 to 51.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Relevant for this endpoint was disease status at 3 y.Population: The analysis dataset is comprised of all treated patients.
3-year progression-free survival rate is defined as the proportion of patients absent death or progression based on WHO criteria by 3 years since time of treatment start. PD is a \>/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
ISM Good Risk Group
n=120 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
3-Year Progression-Free Survival Rate
|
.108 proportion of participants
Interval 0.065 to 0.167
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=23 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=84 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
n=13 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by MSKCC Risk Group
|
.22 proportion of participants
Interval 0.07 to 0.44
|
.25 proportion of participants
Interval 0.16 to 0.36
|
.31 proportion of participants
Interval 0.09 to 0.61
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=10 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=102 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
n=8 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by UCLA SANI Score
|
.20 proportion of participants
Interval 0.03 to 0.56
|
.27 proportion of participants
Interval 0.19 to 0.37
|
.00 proportion of participants
Interval 0.0 to 0.37
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=114 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=5 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by Tumor Type
|
.26 proportion of participants
Interval 0.19 to 0.35
|
.00 proportion of participants
Interval 0.0 to 0.52
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Response status was confirmed by an independent assessment of radiographs. Participants received up to 3 courses of 12 weeks duration each.Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.
Outcome measures
| Measure |
ISM Good Risk Group
n=11 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=83 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
n=25 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by Clear Cell Histology Risk Group
|
.27 proportion of participants
Interval 0.06 to 0.61
|
.24 proportion of participants
Interval 0.15 to 0.35
|
.28 proportion of participants
Interval 0.12 to 0.49
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=78 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=39 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by CA-9 Score (CAIX Classification)
|
.33 proportion of participants
Interval 0.19 to 0.5
|
.22 proportion of participants
Interval 0.13 to 0.33
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=95 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=18 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by PD-L1 Tumor
|
.19 proportion of patients
Interval 0.12 to 0.28
|
.50 proportion of patients
Interval 0.26 to 0.74
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=29 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=86 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by B7-H3 Tumor
|
.11 proportion of participants
Interval 0.02 to 0.28
|
.29 proportion of participants
Interval 0.2 to 0.4
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).Population: The analysis dataset is comprised of all treated patients with available tumor tissue/data.
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.
Outcome measures
| Measure |
ISM Good Risk Group
n=66 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
n=12 Participants
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Objective Response Rate by CA-9 SNP
|
.20 proportion of participants
Interval 0.11 to 0.31
|
.33 proportion of participants
Interval 0.1 to 0.65
|
—
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Median survival follow-up was X months (95% CI: ).Population: The analysis dataset is comprised of all treated patients.
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from treatment start to date of disease progression (PD) or death. Per WHO criteria: PD is a \>/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. Participants who were event-free were censored at the date of their last disease evaluation.
Outcome measures
| Measure |
ISM Good Risk Group
n=120 Participants
ISM \[Atkins et al CCR 2005\]:
Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining
Pathology \[Upton et al. J Immunother 2005\] Good predictive pathology: clear-cell histology AND no papillary features AND \>50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (\>0%) alveolar features AND 50% granular features
CAIX \[Bui et al. CCR 2003\] High CAIX staining: \>85% of CAIX positive tumor cells
|
Intermediate MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
Poor MSKCC Risk Group
MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
|
|---|---|---|---|
|
Progression-Free Survival
|
4.2 months
Interval 2.5 to 4.7
|
—
|
—
|
Adverse Events
HD IL2
Serious adverse events
| Measure |
HD IL2
n=120 participants at risk
Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Cardiac disorders
Cardiac-ischemia
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Cardiac disorders
Cardiac-other
|
1.7%
2/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
General disorders
Fatigue
|
2.5%
3/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
General disorders
Fever w/o neutropenia
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
General disorders
Constitutional, other
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Investigations
Lymphopenia
|
1.7%
2/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Investigations
Platelets
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Investigations
Bilirubin
|
2.5%
3/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Investigations
Creatinine
|
2.5%
3/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
2/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Psychiatric disorders
Confusion
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
2/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Vascular disorders
Hypotension
|
1.7%
2/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
Other adverse events
| Measure |
HD IL2
n=120 participants at risk
Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
|
|---|---|
|
Renal and urinary disorders
Renal failure
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
|
Eye disorders
Uveitis
|
0.83%
1/120 • Adverse events were assessed continuously throughout treatment. Treatment duration was a median of 3 courses (duration of 12 weeks each) in this study cohort. Note: one grade 2 serious adverse event (SAE), one grade 3 other adverse event (OAE) and one grade 4 OAE are missing from the tables because codes/description of these events are unknown but these patients are included in the overall number affected.
Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (max grade) with trt-attribution of possibly, probably or definitely.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place