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 Completed 16 to 80 CENOG-7231

Objectives

I.  Evaluate the tumor response to Single-agent Chemotherapy with adriamycin 
(ADR) and to combination chemotherapies with actinomycin-D/melphalan 
(ACT-D/L-PAM) with and without vincristine (VCR) and cycloleucine (CYL) in 
patients with sarcomas of mesenchymal origins.
II.  Evaluate cross-over to combination therapies upon progression in patients 
treated with ADR only, and cross-over to ADR therapy for patients not 
responsive to combination chemotherapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients between 16 and 80 years of 
age with measurable incurable sarcomas including soft-tissue sarcomas 
(liposarcoma, rhabdomyosarcoma, synovial and fibrosarcoma) and bone and 
cartilage sarcomas (osteogenic sarcoma, chondrosarcoma and Ewing's sarcoma) as 
well as sarcomas of undetermined histiogenesis.  Patients must have adequate 
hematological, hepatic and renal functions, with CPK less than 120% of the 
upper value of the normal range and a life expectancy of at least 3 months.

Expected Enrollment

Protocol closed 10/75.

Outline

Randomized Study.  Induction and Maintenance.
Arm I:  2-Drug Combination Chemotherapy.  Actinomycin-D, ACT-D, NSC-3053; 
Melphalan, L-PAM, NSC-8806.
Arm II:  3-Drug Combination Chemotherapy.  ACT-D, L-PAM, plus Vincristine, 
VCR, NSC-67574.
Arm III:  3-Drug Combination Chemotherapy.  ACT-D, L-PAM, plus cycloleucine, 
CYL, NSC-1026.
Arm IV:  Single-agent Chemotherapy.  Adriamycin, ADR, NSC-123127.

Trial Contact Information

Trial Lead Organizations

Central Oncology Group

William Fletcher, MD, Protocol chair		Ph: 503-494-8478; 800-494-1234 Email: fletchew@ohsu.edu