Trial Outcomes & Findings for A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer. (NCT NCT00199836)
NCT ID: NCT00199836
Last Updated: 2022-10-10
Results Overview
Blood samples were obtained at baseline (prior to the first dose), prior to the second, third and fourth injection and 2 weeks after the fourth injection in both cycles 1 and 2 for the assessment of NY-ESO-1 specific antibodies by an enzyme-linked immunosorbent assay (ELISA). A positive response was a readable optical density at 280 nm.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
up to 27 weeks
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and progressive disease (PD), a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
|
Overall Study
STARTED
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14
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and progressive disease (PD), a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
|
Overall Study
Progressive Disease
|
5
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|
Overall Study
Death
|
1
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Baseline Characteristics
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
Baseline characteristics by cohort
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 Participants
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and progressive disease (PD), a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 27 weeksPopulation: All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had pre- and post-treatment samples taken.
Blood samples were obtained at baseline (prior to the first dose), prior to the second, third and fourth injection and 2 weeks after the fourth injection in both cycles 1 and 2 for the assessment of NY-ESO-1 specific antibodies by an enzyme-linked immunosorbent assay (ELISA). A positive response was a readable optical density at 280 nm.
Outcome measures
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 Participants
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
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Number of Patients With NY-ESO-1 Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Number of patients with negative titers both pre- and post-treatment
|
8 Participants
|
|
Number of Patients With NY-ESO-1 Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Number of patients with positive titers both pre- and post-treatment
|
5 Participants
|
|
Number of Patients With NY-ESO-1 Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Number of patients with negative titers at baseline and positive titers after treatment
|
1 Participants
|
PRIMARY outcome
Timeframe: up to 27 weeksPopulation: All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had pre- and post-treatment samples taken were included in the Cycle 1 results. Cycle 2 results include all patients who received Cycle 2 treatment.
Blood samples were obtained at baseline, prior to the second, third and fourth injection and 2 weeks after the fourth injection in both cycles 1 and 2 for the assessment of NY-ESO-1b specific CD8+ T-cells by ELISPOT assays.
Outcome measures
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 Participants
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
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Number of Patients With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1b Specific CD8+ T-cells Following Treatment.
Number of patients with an increase in NY-ESO-1b specific CD8+ T-cells during cycle 1
|
4 Participants
|
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Number of Patients With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1b Specific CD8+ T-cells Following Treatment.
Number of patients without an increase in NY-ESO-1b specific CD8+ T-cells during cycle 1
|
10 Participants
|
|
Number of Patients With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1b Specific CD8+ T-cells Following Treatment.
Number of patients with an increase in NY-ESO-1b specific CD8+ T-cells during cycle 2
|
5 Participants
|
PRIMARY outcome
Timeframe: up to 25 weeksPopulation: All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had pre- and post-treatment assessments at the given timeframes. One patient did not have post-injection DTH testing.
10 mcg NY-ESO-1b peptide was injected intradermally at a separate site from the vaccination at baseline and after the second and fourth injection of each cycle. Assessment of DTH reactions as evidenced by redness and induration was performed 48 h after injection. The number of patients with DTH positive skin reactions was reported at each timepoint.
Outcome measures
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 Participants
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
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Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Baseline · Number of Patients With DTH Skin Reactions
|
2 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Baseline · Number of Patients Without DTH Skin Reactions
|
12 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 4 · Number of Patients With DTH Skin Reactions
|
0 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 4 · Number of Patients Without DTH Skin Reactions
|
13 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 10 · Number of Patients With DTH Skin Reactions
|
1 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 10 · Number of Patients Without DTH Skin Reactions
|
7 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 19 · Number of Patients With DTH Skin Reactions
|
3 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 19 · Number of Patients Without DTH Skin Reactions
|
2 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 25 · Number of Patients With DTH Skin Reactions
|
1 Participants
|
|
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
Week 25 · Number of Patients Without DTH Skin Reactions
|
4 Participants
|
PRIMARY outcome
Timeframe: up to 28 weeksPopulation: All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51.
DLT was defined as the following toxicities definitely, probably, or possibly related to the administration of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51: * ≥ Grade 2 autoimmune phenomena * Asymptomatic bronchospasm or generalized urticaria * ≥ Grade 3 hematological and non hematological toxicities.
Outcome measures
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 Participants
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
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Safety as Measured by the Number of Patients With Dose Limiting Toxicities (DLT)
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 28 weeksPopulation: All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had at least one tumor response assessment.
Computed tomography (CT) scans were performed at screening, and during weeks 13 and 28. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. No evidence of disease (NED): no target or non-target lesions at baseline and no new lesions identified on post-baseline scans.
Outcome measures
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 Participants
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
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Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
3 Participants
|
|
Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
|
0 Participants
|
|
Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
0 Participants
|
|
Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
No Evidence of Disease
|
2 Participants
|
|
Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
|
9 Participants
|
Adverse Events
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
Serious events: 6 serious events
Other events: 14 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 participants at risk
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection of peptide. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
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Cardiac disorders
Angina pectoris
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
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General disorders
Asthenia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastases
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Hepatobiliary disorders
Cholecystitis
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Gastrointestinal disorders
Pancreatitis
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Nervous system disorders
Convulsion
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Injury, poisoning and procedural complications
Overdose
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Gastrointestinal disorders
Gastroenteritis
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Cardiac disorders
Cardiac failure
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Cardiac disorders
Tachyarrhythmia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
Other adverse events
| Measure |
Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.
n=14 participants at risk
NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection of peptide. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.
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|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
3/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Application site eczema
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Gastrointestinal disorders
Ascites
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Axillary pain
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
3/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Brain edema
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Surgical and medical procedures
Catheter placement
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Chills
|
28.6%
4/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Cardiac disorders
Dyspnea exertional
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Fatigue
|
21.4%
3/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Flu-like symptoms
|
28.6%
4/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Hepatobiliary disorders
Gamma glutamyl transferase elevated
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Gastrointestinal disorders
Gastric ulcer
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Gastrointestinal disorders
Gastrointestinal infection
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Hepatobiliary disorders
Hepatomegaly
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Infections and infestations
Herpes simplex
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Hypertonia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Hypothermia
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Inflammation
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Injection site induration
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Injection site reaction
|
28.6%
4/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Investigations
Karnofsky scale worsened
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
28.6%
4/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Pain
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
General disorders
Pyrexia
|
28.6%
4/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Surgical and medical procedures
Resection of metastasis
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Psychiatric disorders
Restlessness
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Psychiatric disorders
Sleep disturbance
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Nervous system disorders
Trigeminal neuralgia
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezes
|
7.1%
1/14 • Up to 28 weeks.
All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place