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

Alternate Title

Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0209063 GENZ-DCREN-005-01

Objectives

1. Determine the safety of vaccination with allogeneic dendritic cells electrofused with autologous tumor cells in patients with stage IV renal cell carcinoma.
2. Determine the tumor response in patients treated with this vaccination.
3. Determine the immune response in patients treated with this vaccination.
4. Determine the overall survival and time to disease progression in patients treated with this vaccination.

Entry Criteria

Disease Characteristics:

• Diagnosis of renal cell carcinoma
  • Stage IV
  • Primary or relapsed disease



• Previously received and failed 1 prior interleukin-2 therapy OR never received IL-2 therapy



• Accessible tumor for vaccine production (at least 2.5 cm in diameter in aggregate)



• Measurable tumor lesions remaining after resection of tumor used for vaccine production
  • Measurable disease must be outside any prior radiotherapy port or intratumoral treatment area (unless there is documented tumor progression after completion of the therapy)



• No active or clinically significant CNS metastases

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• More than 30 days since prior nononcologic investigational biologic therapy
• No other concurrent biologic therapy for malignancy

Chemotherapy

• No prior chemotherapy for renal cell carcinoma
• No concurrent systemic chemotherapy for malignancy

Endocrine therapy

• No concurrent chronic oral steroid treatment

Radiotherapy

• See Disease Characteristics
• More than 2 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 2 weeks since prior treatment for renal cell carcinoma
• More than 30 days since prior nononcologic investigational drugs or medical devices
• No more than 2 prior regimens for the treatment of renal cell carcinoma
• No other concurrent participation in studies utilizing investigational products
• No concurrent chronic immunosuppressive treatment

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• No clinically significant hematologic disease

Hepatic

• Bilirubin less than 2.0 mg/dL
• AST and ALT less than 2.0 times upper limit of normal
• No clinically significant hepatic disease

Renal

• Creatinine less than 2.0 mg/dL
• No clinically significant renal disease

Cardiovascular

• No clinically significant cardiac disease

Immunologic

• HIV-1 and HIV-2 negative
• HTLV-1 negative
• No clinically significant autoimmune disorder
• No active infection requiring parenteral antibiotics

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study treatment
• No prior unrelated or second malignancy within the past 5 years except nonmelanoma skin cancer or in situ carcinomas
• No underlying condition that would contraindicate study therapy or confuse interpretation of study results
• No other reason, in the investigator's opinion, that would preclude study compliance or compromise ability to give informed consent

Expected Enrollment

A maximum of 40 patients will be accrued for this study.

Outline

This is an open-label, multicenter study.

Patients undergo surgery to obtain tumor to create the vaccine product. Dendritic cells are prepared from donor blood.

Within 6 weeks after surgery, patients are immunized with allogeneic dendritic cells electrofused with autologous tumor cells subcutaneously on days 0, 42, and 84 in the absence of unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 3 years.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Robert Figlin, MD, FACP, Principal investigator(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719

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