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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 65 and under FHCRC-81 NCI-V83-0092

Objectives

I.  Determine the maximum tolerated single dose of of dimethylbusulfan that 
can be given when followed by autologous marrow infusion.
II.  Evaluate the therapeutic response and duration of response to treatment 
with dimethylbusulfan followed by autologous marrow infusion in patients with 
a variety of resistant malignancies.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with malignancies known to 
be resistant to available chemotherapeutic agents and radiotherapy will be 
treated on protocol as initial therapy.  Other patients will have failed to 
respond to conventional chemotherapy and will have little probability of 
responding to available agents.  All patients must have measurable tumor 
without marrow involvement and must have adequate marrow function.  Eligible 
tumors include lung carcinoma, ovarian carcinoma, bowel carcinoma, melanoma, 
soft tissue sarcomas, head and neck tumors, and anaplastic carcinomas with 
unknown primaries.  The upper age limit is 65 years and the minimum life 
expectancy is 30 days.  There may be no significantly abnormal functioning of 
liver, kidneys, heart, or lungs.  Patients should not have received prior 
high-dose irradiation of large volumes of marrow.

Expected Enrollment

Not given.

Outline

Nonrandomized study.
Single-agent Chemotherapy followed by Autologous Bone Marrow Infusion.  
Dimethylbusulfan, Dimethylmyleran, DMM; plus autologous bone marrow.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

C. Dean Buckner, MD, Protocol chair(Contact information may not be current)		Ph: 206-667-4692