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


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Laurence Elias, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066654

NCT ID:

NCT00003585

Start Date:

August 1996

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131