Biological Therapy Plus Chemotherapy in Treating Patients With Metastatic or Recurrent Kidney Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Cancer
Intervention: aldesleukin (Drug); fluorouracil (Drug); isotretinoin (Drug); recombinant interferon alfa (Drug); surgical procedure (Procedure)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: University of New Mexico Official(s) and/or principal investigator(s):
Laurence Elias, MD, Study Chair, Affiliation: University of New Mexico
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.
Clinical Details
Official title: A Phase I/II Pilot Study of a Novel Four Drug Regimen for the Treatment of Advanced Renal Cell Carcinoma: FUNIL-cRA
Study design: Treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic and/or recurrent renal cell
carcinoma Bidimensionally measurable disease No concurrent brain metastases Patients with
prior brain metastases who have undergone radiation and/or surgery, with stable response,
confirmed by MRI, and off corticosteroids are eligible
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-1 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Not pregnant or nursing Fertile patients must use effective contraception No other
serious illness or active infection requiring antibiotics Not HIV positive No active
substance abuse
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior interleukin-2
therapy At least 6 months since prior interferon alfa therapy At least 1 month since other
prior biologic therapy No other concurrent biologic therapy (e. g., filgrastim or
sargramostim) Chemotherapy: At least 6 months since prior fluorouracil therapy At least 1
month since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least
1 month since prior endocrine therapy No concurrent hormone therapy No concurrent
corticosteroids except if inhaled or topical Radiotherapy: At least 1 month since prior
radiotherapy (to less than 25% of the bone marrow only, and there must be measurable
disease outside of radiation field) No concurrent radiotherapy Surgery: At least 3 weeks
since prior surgery Other: No concurrent ongoing therapy with investigational drugs
Locations and Contacts
University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico 87131, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1996
Last updated: May 23, 2008
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