6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients who have refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Irofulven

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of refractory myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia MDS and AML include:

• First salvage with primary refractory disease or first complete remission of no more than 12 months

• Second or greater salvage

• After the maximum tolerated dose is determined, AML patients with an intermediate prognosis (i.e., complete remission of more than 12 months, but less than 24 months) are eligible

• No candidates for curative therapies such as allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

• Age: 18 and over

• Performance status: Zubrod 0-2

• Bilirubin no greater than 1.5 mg/dL

• Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

• No active congestive heart failure

• No uncontrolled angina

• No myocardial infarction within past 6 months

• No concurrent grade 4 infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No overt psychosis, mental disability, or other incompetency that would preclude obtaining informed consent

• No life threatening nonmalignant illness

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior biologic therapy and recovered

• No concurrent systemic anticancer biologic therapy

• At least 2 weeks since other prior chemotherapy and recovered

• Concurrent hydroxyurea allowed if needed to control blast counts

• No concurrent systemic anticancer chemotherapy

• At least 2 weeks since prior endocrine therapy and recovered

• Concurrent corticosteroids allowed if needed to control blast counts

• At least 2 weeks since prior radiotherapy and recovered

• No concurrent systemic radiotherapy

• No concurrent surgery

• At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered

• No other concurrent investigational drugs