Trial · NCT00070070
Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
NCT00070070, Phase 1, Completed, Ludwig Institute for Cancer Research; results first posted 2021-07-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas. Trials, record NCT00070070. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00070070
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
- NCT number
- NCT00070070
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Ludwig Institute for Cancer Research
- Conditions
- Transitional Cell Carcinoma
- Interventions
- TICE®-strain BCG, NY-ESO-1 protein, sargramostim
- First posted
- 2003-10-07
- Last updated
- 2022-10-12
- Results first posted
- 2021-07-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities | 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. |
| Secondary | Number of Patients Developing NY-ESO-1 Antibodies After Treatment | 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). |
| Secondary | Number of Patients With CD4+ and CD8+ T-cell Responses. | 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. |
| Secondary | Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities | up to 12 weeks | All participants who received at least one study treatment. One participant in Cohort 4 did not have HLA-A2 status tested. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Developing NY-ESO-1 Antibodies After Treatment | up to 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With CD4+ and CD8+ T-cell Responses. | up to 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint | up to 8 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities | Cohort 1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Cohort 2 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Cohort 3 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Cohort 4 | 0 | Participants | ||
| Number of Patients Developing NY-ESO-1 Antibodies After Treatment | Cohort 1 | Number of Participants with NY-ESO-1 Antibodies at Baseline and After Treatment | 1 | Participants | |
| Number of Patients Developing NY-ESO-1 Antibodies After Treatment | Cohort 2 | Number of Participants with NY-ESO-1 Antibodies at Baseline and After Treatment | 0 | Participants | |
| Number of Patients Developing NY-ESO-1 Antibodies After Treatment | Cohort 3 | Number of Participants with NY-ESO-1 Antibodies at Baseline and After Treatment | 0 | Participants | |
| Number of Patients Developing NY-ESO-1 Antibodies After Treatment | Cohort 4 | Number of Participants with NY-ESO-1 Antibodies at Baseline and After Treatment | 0 | Participants | |
| Number of Patients Developing NY-ESO-1 Antibodies After Treatment | Cohort 1 | Number of Participants with No NY-ESO-1 Antibodies at Baseline and Antibodies After Treatment | 0 | Participants | |
| Number of Patients Developing NY-ESO-1 Antibodies After Treatment | Cohort 2 | Number of Participants with No NY-ESO-1 Antibodies at Baseline and Antibodies After Treatment | 0 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 1 | |
| Overall Study | STARTED | Cohort 2 | 0 | |
| Overall Study | STARTED | Cohort 3 | 0 | |
| Overall Study | STARTED | Cohort 4 | 5 | |
| Overall Study | COMPLETED | Cohort 1 | 1 | |
| Overall Study | COMPLETED | Cohort 2 | 0 | |
| Overall Study | COMPLETED | Cohort 3 | 0 | |
| Overall Study | COMPLETED | Cohort 4 | 5 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood calcium decreased | Investigations | Cohort 1 | 0 | 1 | |
| other | Blood calcium decreased | Investigations | Cohort 2 | 0 | 0 | |
| other | Blood calcium decreased | Investigations | Cohort 3 | 0 | 0 | |
| other | Blood calcium decreased | Investigations | Cohort 4 | 1 | 5 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Cohort 1 | 0 | 1 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Cohort 2 | 0 | 0 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Cohort 3 | 0 | 0 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Cohort 4 | 1 | 5 | |
| other | Fatigue | General disorders | Cohort 1 | 0 | 1 | |
| other | Fatigue | General disorders | Cohort 2 | 0 | 0 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 1 |
| Total, all-cause mortality | Cohort 2 | 0 | 0 |
| Total, all-cause mortality | Cohort 3 | 0 | 0 |
| Total, all-cause mortality | Cohort 4 | 0 | 5 |
| Total, other adverse events | Cohort 1 | 1 | 1 |
| Total, other adverse events | Cohort 2 | 0 | 0 |
| Total, other adverse events | Cohort 3 | 0 | 0 |
| Total, other adverse events | Cohort 4 | 5 | 5 |
| Total, serious adverse events | Cohort 1 | 0 | 1 |
| Total, serious adverse events | Cohort 2 | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18833002 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00070070
GET https://conductscience.org/api/trials/v1/NCT00070070/results?page=2