Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2 for Patients With Stage IV Renal Cell Carcinoma
18 Years
N/A
Both
Kidney Cancer
Trial Information
Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2 for Patients With Stage IV Renal Cell Carcinoma
OBJECTIVES:
- Determine the percentage of patients with stage IV renal cell carcinoma with a
reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell
vaccine and interleukin-2.
- Determine the immunogenicity of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the local and systemic toxicity of this regimen in these patients.
OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative
surgical resection of primary tumor or therapeutic resection of metastasis.
At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous
tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the
first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks
(days 43-82). Patients with stable or responding disease after day 106 may receive
additional vaccinations in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks after the last dose of IL-2.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV renal cell carcinoma
- Symptomatic primary tumor or resectable metastasis
- Measurable disease post resection
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group (ECOG) 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
- Hematocrit greater than 30%
Hepatic:
- Bilirubin less than 2 times normal
- SGOT less than 3 times normal
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No contraindications to surgical resection
- No history of immunodeficiency disease
- No known allergy to penicillin
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior interleukin-2, interferon alfa, or other biologic agent allowed
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent corticosteroids (except for replacement doses for adrenal
insufficiency)
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- No concurrent immunosuppressants
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors
Outcome Description:
The primary objective of this phase II trial involving 30 patients will be to determine tumor response rates. The immunogenicity of the treatment will be assessed by ELISPOT assays performed on the patients' peripheral blood lymphocytes, and by an immunohistochemical analysis of DTH skin tests site biopsies performed 48 hours after the intradermal injection of autologous, unmodified tumor cells.
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Scott J. Antonia, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
MCC-12207
NCT ID:
NCT00031564
Start Date:
May 2000
Completion Date:
June 2012
Related Keywords:
- Kidney Cancer
- stage IV
- renal cell carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
