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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00042822 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: romidepsin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study Of FR901228, Or Depsipeptide (NSC #630176) For Adult Patients With Advanced Hematologic Cancers |
| Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed refractory or relapsed acute myeloid leukemia (AML)
Elderly patients with newly diagnosed AML
Histologically confirmed high-risk myelodysplastic syndromes
Eligible subtypes include:
Histologically confirmed intermediate-grade non-Hodgkin's lymphoma (NHL)
Histologically confirmed follicular NHL
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent drugs that may prolong the QTc interval
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Virginia Klimek, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000069473, MSKCC-00116, NCI-1715 |
| Study First Received: | August 5, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00042822 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult acute myeloid leukemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia recurrent grade 3 follicular lymphoma previously treated myelodysplastic syndromes secondary myelodysplastic syndromes untreated adult acute myeloid leukemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
|
Precancerous Conditions Antineoplastic Agents Leukemia, Myeloid, Acute Antibiotics, Antineoplastic Leukemia Preleukemia Pathologic Processes Syndrome Therapeutic Uses Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Disease |
Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Romidepsin Leukemia, Myeloid Pharmacologic Actions Lymphatic Diseases Neoplasms Lymphoproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Lymphoma, Non-Hodgkin Bone Marrow Diseases |