Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 20 to 70 MSHMC-REN-2

Objectives

I.  Compare the effectiveness of 2 regimens employing a combination of 
cytotoxic and hormonal agents with or without immunotherapy using C. parvum in 
the treatment of metastatic renal carcinoma.  Crossover for patients with 
disease progression.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with renal cell carcinoma 
(adenocarcinoma, hypernephroma) or unequivocal arteriographic evidence of an 
inoperable primary lesion.  Patients must be between 20 and 70 years of age, 
with expected survival exceeding 2 months.  Patients may not have received 
prior cytotoxic-agent treatment, but may have received prior hormonal therapy.

Expected Enrollment

Protocol closed as of October 1979; 17 patients have been entered.

Outline

Randomized study.
Arm I:  3-Drug Combination Chemotherapy plus Hormone Therapy.  Adriamycin, 
ADR, NSC-123127; CCNU, CCNU, NSC-79037; Vincristine, VCR, NSC-67574; plus 
Fluoxymesterone, FXM, NSC-12165.
Arm II:  Single-agent Chemotherapy plus Hormone Therapy plus Immunotherapy.  
Cyclophosphamide, CTX, NSC-26271; plus Medroxyprogesterone acetate, MPA, 
NSC-26386; plus Corynebacterium parvum, Burroughs-Wellcome, C. parvum, B.W., 
NSC-220537.

Trial Contact Information

Trial Lead Organizations

Penn State Cancer Institute at Milton S. Hershey Medical Center

Harold Harvey, MD, Protocol chair		Ph: 717-531-8677 Email: hharvey@psu.edu