Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	MCC-12207 MCC-IRB-5620, NCI-5090, NCI-G00-1872, NCT00031564

Objectives

1. 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.
2. Determine the immunogenicity of this regimen in these patients.
3. Determine the overall survival of patients treated with this regimen.
4. Determine the local and systemic toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IV renal cell carcinoma
  • Symptomatic primary tumor or resectable metastasis



• Measurable disease post resection



• No symptomatic brain metastases

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

Approximately 30 patients will be accrued for this study.

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.

Fishman M, Hunter TB, Soliman H, et al.: Phase II trial of B7-1 (CD-86) transduced, cultured autologous tumor cell vaccine plus subcutaneous interleukin-2 for treatment of stage IV renal cell carcinoma. J Immunother 31 (1): 72-80, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Scott Antonia, MD, PhD, Protocol chair		Ph: 813-972-8400, ext. 2677; 888-663-3488

Registry Information
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
Trial Start Date		2002-01-29
Registered in ClinicalTrials.gov		NCT00031564
Date Submitted to PDQ		2000-08-29
Information Last Verified		2004-04-08
NCI Grant/Contract Number		CA76292, CA82059