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Chemotherapy with ADR, MTX with & without Adjuvant Immunotherapy with BCG & Allogeneic Tumor Cell Vaccine in Skeletal & Soft Tissue Sarcoma

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Treatment Closed 5 to 70 UCLA-SAR-1

Objectives

I.  Compare the efficacy of adjuvant immunotherapy with BCG and allogeneic 
tumor cell vaccine plus chemotherapy with adriamycin (ADR) and high-dose 
methotrexate (MTX) to chemotherapy alone in patients with skeletal and soft 
tissue sarcoma.
II.  Compare the improvement in disease-free and overall survival between 
these two regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 5 to 70 years of age with 
Stage I, Grade III skeletal and soft tissue sarcoma.

Expected Enrollment

110 patients have been entered as of February 1980.  Protocol closed 04/81.

Outline

Randomized study.  Patients randomized after surgery.
Arm I:  2-Drug Combination Chemotherapy.  Adriamycin, ADR, NSC-123127; 
high-dose Methotrexate, HD-MTX, NSC-740.
Arm II:  2-Drug Combination Chemotherapy plus Immunotherapy.  ADR; MTX; plus 
BCG-Tice, BCG, NSC-B116327, and allogeneic tumor cell vaccine.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Frederick Eilber, MD, Protocol chair
Ph: 310-825-7086; 888-798-0719

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.