18 and older, any sex, with Transitional Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose Limiting ToxicitiesPrimary· up to 12 weeks
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.
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
Number of Patients Developing NY-ESO-1 Antibodies After TreatmentSecondary· up to 12 weeks
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).
Group
Value
95% CI
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
0
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
4
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
1
Number of Patients With CD4+ and CD8+ T-cell Responses.Secondary· up to 12 weeks
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.
CD4+ T-Cell Responses
Group
Value
95% CI
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
5
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
0
CD8+ T-Cell Responses
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
1
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
4
Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each TimepointSecondary· up to 8 weeks
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.
Baseline
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
2
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
3
Week 3
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
2
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
2
Week 8
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Cohort 3
0
Cohort 4
1
Cohort 1
1
Cohort 2
0
Cohort 3
0
Cohort 4
3
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 12 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as Bacille Calmette Guerin (BCG) and sargramostim (GM-CSF), use different ways to stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving vaccine therapy together with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell carcinomas.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ludwig Institute for Cancer Research
Last refreshed: 12 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00070070.