FR901228 in Treating Patients With Hematologic Cancer

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00024180

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Drug: romidepsin	Phase 1

Detailed Description

OBJECTIVES:

Determine the in vivo biologic effect of FR901228 (depsipeptide) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, or acute lymphoblastic leukemia.
Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients.
Determine any preliminary anti-tumor activity of this drug in these patients.

OUTLINE: This is a dose-decreasing, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia).

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined. If 5 or more patients show clinical or biological response, the subsequent cohort is treated at a lower dose. If fewer than 5 patients respond, the subsequent cohort is treated at a higher dose.

PROJECTED ACCRUAL: A minimum of 20 patients (10 per stratum) will be accrued for this study.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)

Study Start Date :

Jan 1, 2002

Actual Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)