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

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Not specified	Other	UNM-0996C NCI-V98-1478, NCT00003585

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.

Entry 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

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

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 

Expected Enrollment

A total of 35 patients will be accrued to this study.

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.

Trial Contact Information

Trial Lead Organizations

University of New Mexico Cancer Center

Laurence Elias, MD, Protocol chair(Contact information may not be current)		Ph: 505-272-5837 Email: lelias@salud.unm.edu

Registry Information
Official Title		A Phase I/II Pilot Study of a Novel Four Drug Regimen for the Treatment of Advanced Renal Cell Carcinoma: FUNIL-cRA
Trial Start Date		1996-08-20
Registered in ClinicalTrials.gov		NCT00003585
Date Submitted to PDQ		1998-09-24
Information Last Verified		2000-08-01

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