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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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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 InstituteTampa, Florida  33612