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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Guido Marcucci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068898

NCT ID:

NCT00024180

Start Date:

January 2002

Completion Date:

August 2006

Related Keywords:

  • Leukemia
  • Lymphoma
  • Waldenström macroglobulinemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • refractory chronic lymphocytic leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • recurrent small lymphocytic lymphoma
  • Leukemia
  • Lymphoma

Name

Location

Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210