NCT00003585

Biological Therapy Plus Chemotherapy in Treating Patients With Metastatic or Recurrent Kidney Cancer

A Phase I/II Pilot Study of a Novel Four Drug Regimen for the Treatment of Advanced Renal Cell Carcinoma: FUNIL-cRA

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of biological therapy plus chemotherapy in treating patients with metastatic or recurrent kidney cancer.

Detailed description

OBJECTIVES: I. Evaluate the toxic effects, patient tolerance, and practicality of administering interferon alfa-2b, fluorouracil, interleukin-2, and isotretinoin (FUNIL-cRa) in patients with metastatic and/or recurrent renal cell carcinoma. II. Obtain a pilot indication of responsiveness of these patients to this regimen. III. Evaluate the measurement of tumor thymidylate synthetase as a prediction of response of these patients to this and other fluorouracil based regimens. OUTLINE: Patients are stratified by performance status (0 vs 1), nephrectomy (yes vs no), site of disease (pulmonary or lymph node metastases only vs other disease site), radiotherapy (yes vs no), and prior adjuvant biologic or hormone therapy (yes vs no). Patients receive intravenous fluorouracil daily for 14 days, and subcutaneous interferon alfa-2b 3 times a week for 6 weeks. Beginning on day 15, patients receive intravenous interleukin-2, 5 days a week and oral isotretinoin 2 times a day for 4 weeks. Treatment courses are 6 weeks, followed by a 2 week rest period. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with partial or complete response may undergo surgical resection. Patients are followed every 2 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 35 patients will be accrued to this study.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	recombinant interferon alfa
DRUG	fluorouracil
DRUG	isotretinoin
PROCEDURE	surgical procedure

Timeline

• Start date: 1996-08-01
• Primary completion: 2001-08-01
• Completion: 2002-08-01
• First posted: 2004-07-22
• Last updated: 2013-12-10

Locations

1 site across 1 country: United States