Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2
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Purpose
RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: Interleukin-2 Biological: B7-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors [ Time Frame: 4 years ] [ Designated as safety issue: No ]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.
| Enrollment: | 49 |
| Study Start Date: | May 2000 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaccine Therapy With Interleukin-2
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.
|
Biological: Interleukin-2
Other Names:
Biological: B7-1
Other Name: gene-modified autologous tumor cell vaccine
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: | Scott J. Antonia, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00031564 History of Changes |
| Other Study ID Numbers: | MCC-12207, NCI-5090, NCI-G00-1872, 0001386 |
| Study First Received: | March 8, 2002 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
stage IV renal cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013