Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	no age specified	NCI	EST-1882

Objectives

I.  Evaluate single-agent or combination therapy to determine drug activity 
and influence on survival in patients with advanced renal cell cancer.
II.  Use an addendum design to add new treatment arms in order to promote a 
more rapid replacement program for drug testing.
III.  Allow for data input and analysis on an adequate number of patients 
while a replacement treatment addendum program is under trial and actively 
accruing patients.
IV.  Compare (in this portion of the Master Protocol) the therapeutic efficacy 
of vinblastine vs. L-alanosine in patients with advanced renal adenocarcinoma 
not suitable for surgical treatment.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologic proof of 
measurable renal adenocarcinoma not amenable to surgical cure and, where 
possible, histologic proof of recurrent or metastatic disease.  Patients may 
have had one prior chemotherapeutic regimen provided that none of the study 
agents were included.  At least 3 weeks must have elapsed since any major 
surgical procedure with resection and at least 2 weeks since exploration and 
biopsy only.  Any hormonal treatment must be discontinued at the time of 
entry; no chemotherapy or radiotherapy is allowed during the month prior to 
entry unless evidence of progressive disease has been documented and 
associated toxicities have abated.  There may be no active infectious process, 
and nutritional status must be adequate.  The performance status must be 0-2, 
and marrow, liver, and kidney function must be adequate.

Expected Enrollment

About 30 patients (at least 14 with no prior chemotherapy) will be entered on 
each treatment arm.  Protocol closed July 1984 with accrual objective met.

Outline

Randomized study.  As of Addenda 2 and 3, May 1983, and within the framework 
of the Master Protocol, Arms I and II have been closed, with accrual goals 
met, and have been replaced by Arms III, IV, and V.
Arm I:  Single-agent Chemotherapy.  Vinblastine, VBL, NSC-49842.
Arm II:  Single-agent Chemotherapy.  L-Alanosine, NSC-153353.
Arm III:  Single-agent Chemotherapy.  Acivicin, AT-125, NSC-163501.
Arm IV:  Single-agent Chemotherapy plus Chemosensitization.  Cyclophosphamide, 
CTX, NSC-26271; plus Misonidazole, MNI, NSC-261037.
Arm V:  Single-agent Chemotherapy.  Aminothiadiazole, ATDA, NSC-4728.

Glover D, Trump D, Kvols L, et al.: Phase II trial of misonidazole (MISO) and cyclophosphamide (CYC) in metastatic renal cell carcinoma. Int J Radiat Oncol Biol Phys 12 (8): 1405-8, 1986.[PUBMED Abstract]

Elson PJ, Kvols LK, Vogl SE, et al.: Phase II trials of 5-day vinblastine infusion (NSC 49842), L-alanosine (NSC 153353), acivicin (NSC 163501), and aminothiadiazole (NSC 4728) in patients with recurrent or metastatic renal cell carcinoma. Invest New Drugs 6 (2): 97-103, 1988.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Paul Carbone, MD, Protocol chair(Contact information may not be current)		Ph: 608-265-8047; 800-622-8922 Email: carbone@biostat.wisc.edu