Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
Condition: Transitional Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Intervention: TICE®-strain BCG; NY-ESO-1 protein; sargramostim
Intervention MeSH terms: Sargramostim; BCG Vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This study was open-label, and eligible patients were sequentially entered at the time they presented in clinic. Patients were sequentially assigned to one of four groups according to HLA-A2 characteristic and previous Bacille Calmette Guerin (BCG) therapy.
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder cancer; Renal pelvis cancer

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

          1. Post-cystectomy or post-nephroureterectomy patients with histological confirmation of
             transitional cell carcinoma.

          2. Patients must have had a cystectomy or nephroureterectomy within 16 weeks of first
             vaccination.

          3. At least 4 weeks since surgery prior to receiving the first vaccination.

          4. Radiological imaging to document no evidence of disease within one month prior to
             receiving the first vaccination.

          5. 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) <2.5 X ULN Serum alanine aminotransaminase (ALT)
        (SGPT) <2.5 X ULN 6. Performance status ≤ 2 (ECOG Scale) and life expectancy ≥ 3 months. 7.
        Age ≥ 18 years. 8. Fertile patients must have a negative urine or serum pregnancy test and
        use barrier method contraception before, during and for 6 months after protocol therapy.
        Patients are encouraged to continue barrier method contraception for two years or longer
        after treatment.

        9. Able and willing to give valid written informed consent. Exclusion Criteria

          1. Clinically significant heart disease (NYHA Class III or IV).

          2. Presence of severe reaction to PPD (purified protein derivative) (>40 mm induration).

          3. 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.

          4. Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding
             disorders, antibiotic use within 5 days of treatment.

          5. Previous bone marrow or stem cell transplant.

          6. History of immunodeficiency disease or autoimmune disease.

          7. Known positive HIV test.

          8. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6
             weeks for nitrosoureas).

          9. 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.

         10. Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to enrollment.

         11. Mental disorders that may compromise the ability to give informed consent and comply
             with the requirements of the study.

         12. Lack of availability of the patient for immunological and clinical follow-up
             assessment.

         13. Positive urine or serum pregnancy test.