Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas (NCT NCT00070070)
NCT ID: NCT00070070
Last Updated: 2022-10-12
Results Overview
All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTCAE) (Version 3.0). A Dose limiting toxicity (DLT) was defined as: * ≥ Grade 2 autoimmune phenomena * Asymptomatic bronchospasm or generalized urticaria * ≥ Grade 3 hematological and non hematological toxicities. To be dose limiting, an adverse event must have been definitely, probably, or possibly related to the administration of the study treatment. Patients who experienced a DLT were removed from study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2022-10-12
Participant Flow
Participant milestones
| Measure |
Cohort 1
HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 2
HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 3
HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 4
HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
5
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
Baseline characteristics by cohort
| Measure |
Cohort 1
n=1 Participants
HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 2
HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 3
HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 4
n=5 Participants
HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
—
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All participants who received at least one study treatment. One participant in Cohort 4 did not have HLA-A2 status tested.
All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTCAE) (Version 3.0). A Dose limiting toxicity (DLT) was defined as: * ≥ Grade 2 autoimmune phenomena * Asymptomatic bronchospasm or generalized urticaria * ≥ Grade 3 hematological and non hematological toxicities. To be dose limiting, an adverse event must have been definitely, probably, or possibly related to the administration of the study treatment. Patients who experienced a DLT were removed from study.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 2
HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 3
HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 4
n=5 Participants
HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who received study therapy and had blood samples taken for antibody analysis before and after treatment. One participant in Cohort 4 did not have HLA-A2 status tested.
Blood samples were obtained at baseline, and at weeks 2, 4, 6, 8 and 12 for the assessment of NY-ESO-1 and LAGE-1 specific antibodies by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Cohort 1
n=1 Participants
HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 2
HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 3
HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 4
n=5 Participants
HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
|---|---|---|---|---|
|
Number of Patients Developing NY-ESO-1 Antibodies After Treatment
Number of Participants with NY-ESO-1 Antibodies at Baseline and After Treatment
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Developing NY-ESO-1 Antibodies After Treatment
Number of Participants with No NY-ESO-1 Antibodies at Baseline and No Antibodies After Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Developing NY-ESO-1 Antibodies After Treatment
Number of Participants with No NY-ESO-1 Antibodies at Baseline and Antibodies After Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All participants who received at least one dose of study therapy and had pre- and post-treatment samples taken for analysis. One participant in Cohort 4 did not have HLA-A2 status tested.
Blood samples were obtained at baseline, and at weeks 2, 4, 6, 8 and 12 for the assessment of NY-ESO-1 specific T-cell responses by ELISPOT. T-cell responses were monitored after in vitro sensitization with either overlapping peptides from NY-ESO-1 or recombinant adenovirus encoding NY-ESO-1 (adeno-NY-ESO-1), and with control peptides or recombinant vectors encoding Influenza-derived proteins.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 2
HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 3
HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 4
n=5 Participants
HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
|---|---|---|---|---|
|
Number of Patients With CD4+ and CD8+ T-cell Responses.
CD8+ T-Cell Responses · Number of Participants without Responses
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Patients With CD4+ and CD8+ T-cell Responses.
CD4+ T-Cell Responses · Number of Participants with Responses
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Patients With CD4+ and CD8+ T-cell Responses.
CD4+ T-Cell Responses · Number of Participants without Responses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With CD4+ and CD8+ T-cell Responses.
CD8+ T-Cell Responses · Number of Participants with Responses
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: All participants who received at least one dose of study treatment and received the DTH test at the respective timepoint. One participant in Cohort 4 did not have HLA-A2 status tested.
NY-ESO-1-specific DTH skin reaction was measured at baseline and weeks 3 and 8.The peptide solution (10 μg peptide in 0.1ml normal saline) was injected intradermally at a separate site from the vaccination to give a visible and palpable skin depot. Assessment of DTH reactions was performed 48 h after injection. The extent and intensity of DTH reactions was documented by measuring visible "redness", palpable "induration" and other signs of local skin irritation or necrosis.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 2
HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 3
HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 4
n=5 Participants
HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
|---|---|---|---|---|
|
Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint
Baseline · Number of Participants with Induration and/or Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint
Baseline · Number of Participants with No Induration and/or Redness
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint
Week 3 · Number of Participants with Induration and/or Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint
Week 3 · Number of Participants with No Induration and/or Redness
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint
Week 8 · Number of Participants with Induration and/or Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint
Week 8 · Number of Participants with No Induration and/or Redness
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=1 participants at risk
HLA-A2 Status Positive, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 2
HLA-A2 Status Positive, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 3
HLA-A2 Status Negative, Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
Cohort 4
n=5 participants at risk
HLA-A2 Status Negative, No Previous BCG Therapy; All patients underwent skin testing with the purified protein derivative (PPD) test.
NY-ESO-1 protein, 75 mcg, was administered by intradermal injection every week for 6 weeks. TICE®-strain BCG, 1 x 10E6 viable units in Purified Protein Derivative (PPD) negative patients and 1 x 10E5 viable units in PPD positive (induration greater than or equal to 10 mm) patients, were mixed with each protein vaccination for the first 2 weeks only. For the last 4 weeks GM-CSF, 100 mcg, was mixed with NY-ESO-1 protein given once a week for 4 weeks, intradermally. GM-CSF alone was given subcutaneously on the day prior to the administration of the co-mixture (NY-ESO-1 Protein/GM-CSF) and for 3 days after.
|
|---|---|---|---|---|
|
Investigations
Blood calcium decreased
|
0.00%
0/1 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
20.0%
1/5 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
20.0%
1/5 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
|
General disorders
Fatigue
|
0.00%
0/1 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
40.0%
2/5 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
100.0%
1/1 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
0.00%
0/5 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
|
General disorders
Injection site reaction
|
100.0%
1/1 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
100.0%
5/5 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/1 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
20.0%
1/5 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
|
Cardiac disorders
Peripheral edema
|
0.00%
0/1 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
—
0/0 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE Version 3.0.
|
20.0%
1/5 • up to 12 weeks
All AEs occurring during the study were to be documented in the source records and on the respective Case Report Form Adverse Event page, regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicity was evaluated according to the National Cancer Institute CTCAE 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