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Phase I-II Chemotherapy with Aziridinylbenzoquinone for Previously Treated Acute Leukemia

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I

Treatment

Closed

no age specified

UMCC-8018

Objectives

I.  Determine the toxicity and maximally tolerated dose of 
aziridinylbenzoquinone (AZQ) given as a single daily dose for 7 days in 
patients with previously treated acute leukemia.
II.  Determine the response rate and remission duration in patients treated 
with AZQ.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with bone marrow biopsy- or 
aspirate-confirmed diagnosis of acute undifferentiated leukemia, acute 
lymphocytic (ALL) or acute nonlymphocytic leukemia (ANLL) or blastic phase 
chronic myelocytic leukemia (B-CML).  Patients must have failed conventional 
chemotherapy for their particular leukemia and must not be eligible for any 
other BCRC protocol of higher priority.  Life expectancy must be at least 6 
weeks and performance status at least 30-40 percent (Karnofsky scale).  
Patients must have recovered from prior chemotherapy or radiotherapy.  Bone 
marrow should be normocellular, with at least 30 percent leukemic cells, and 
there must be evidence of progressive leukemia with signs of bone marrow 
failure such as anemia, granulocytopenia or thrombocytopenia.  Adequate 
hepatic and renal function are required; bilirubin must be 1.5 mg dl or less, 
serum creatinine 1.5 mg dl or less.

Expected Enrollment

14 patients will be entered.  Protocol closed 04/81.

Outline

Nonrandomized study.  A preliminary determination of the maximal tolerated 
dose (MTD) of AZQ will be made.
Induction and Maintenance:  Single-agent Chemotherapy.  
Aziridinylbenzoquinone, AZQ, NSC-182986.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

David Van Echo, MD, Protocol chair(Contact information may not be current)
Ph: 410-328-2665; 800-888-8823
Email: dvanecho@umm.edu

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.