FR901228 in Treating Patients With Hematologic Cancer

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.

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

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Romidepsin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of one of the following hematologic malignancies:

• Chronic lymphocytic leukemia (CLL)

• Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)

• Acute myeloid leukemia (AML)

• Acute lymphoblastic leukemia (ALL)

• Stratum I (CLL and SLL):

• Received at least one prior therapy containing a purine analog OR

• Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy

• Stratum II (AML and ALL):

• Primary refractory or relapsed leukemia within the past year that is not amenable to curative therapy

• OR

• Untreated or previously treated poor-risk leukemia defined by any of the following:

• 65 years of age and over

• Poor-risk candidates for aggressive chemotherapy

• Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Stratum I only:

• No uncontrolled autoimmune hemolytic anemia

• No idiopathic thrombocytopenic purpura

• Stratum II only:

• WBC no greater than 10,000/mm^3 OR

• WBC no greater than 40,000/mm^3 that is stable for at least 1 week (may be sustained by hydroxyurea through the first week of study)

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• ALT and AST no greater than 3 times upper limit of normal

Renal:

• Creatinine less than 2.0 mg/dL

Cardiovascular:

• Ejection fraction at least 50% by MUGA

• No myocardial infarction or unstable angina within the past 6 months

• No prior unstable ventricular or supraventricular cardiac arrhythmias

Other:

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other medical or psychiatric problem that would preclude study

• Stratum I only:

• No active infection requiring oral or IV antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 28 days since prior chemotherapy (except hydroxyurea)

• At least 6 weeks since prior nitrosoureas

• At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM)

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• At least 28 days since prior radiotherapy

Surgery:

• At least 28 days since prior major surgery