Phase 1
N=6
Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
Transitional Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00070070 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TICE®-strain BCG (Biological); NY-ESO-1 protein (Biological); sargramostim (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- Jan 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities |
0; 0; 0; 0 | — |
| SECONDARY Number of Patients Developing NY-ESO-1 Antibodies After Treatment |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With CD4+ and CD8+ T-cell Responses. |
1; 0; 0; 5; 0; 0 | — |
| SECONDARY Delayed-type Hypersensitivity (DTH) as Measured by the Number of Participants With Induration and/or Redness at Each Timepoint |
0; 0; 0; 2; 1; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Post-cystectomy or post-nephroureterectomy patients with histological confirmation of transitional cell carcinoma.
- Patients must have had a cystectomy or nephroureterectomy within 16 weeks of first vaccination.
- At least 4 weeks since surgery prior to receiving the first vaccination.
- Radiological imaging to document no evidence of disease within one month prior to receiving the first vaccination.
- Laboratory values within the following limits:
Hemoglobin ≥ 10.0 g/dL Neutrophil count ≥ 1.5 x 10E9/L Lymphocyte count ≥ 0.5 x 10E9/L Platelet count ≥ 100 x 10E9/L Serum creatinine ≤ 1.8 mg/dL Serum bilirubin ≤ 2mg/dL Serum aspartate aminotransferase (AST) (SGOT) 40 mm induration).
- Prior malignancy within 5 years that has been treated with extensive chemotherapy / radiation therapy and have the potential for immune dysfunction or who have evidence of metastasis at the time of registration.
- Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders, antibiotic use within 5 days of treatment.
- Previous bone marrow or stem cell transplant.
- History of immunodeficiency disease or autoimmune disease.
- Known positive HIV test.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
- Concomitant treatment with corticosteroids (within 30 days of enrollment and during treatment), antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless chronically used in low doses for prevention of an acute cardiovascular event or pain control). Topical or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Mental disorders that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
- Positive urine or serum pregnancy test.
Data sourced from ClinicalTrials.gov (NCT00070070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.