Kidney Cancer Clinical Trial
Official title:
A Phase I/II Pilot Study of a Novel Four Drug Regimen for the Treatment of Advanced Renal Cell Carcinoma: FUNIL-cRA
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.
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.
;
Primary Purpose: Treatment
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