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| Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066638 |
Purpose
RATIONALE: Drugs used in chemotherapy such as FR901228 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 relapsed or refractory multiple myeloma.
| Condition | Intervention | Phase |
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: romidepsin |
Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Multiple Myeloma |
| ChemIDplus related topics: | FR 901228 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Depsipeptide (NSC 630176; IND #51, 810) In Relapsed/Refractory Multiple Myeloma |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a stable plateau (stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 5-12.5 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed multiple myeloma
Measurable disease, defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Karnofsky 70-100%
Life expectancy
Hematopoietic
Cytopenias due to myeloma marrow infiltration are allowed provided all of the following are true:
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |||||
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |||||
| Bronx, New York, United States, 10461 | |||||
| Mount Sinai Medical Center | |||||
| New York, New York, United States, 10029 | |||||
| New York Weill Cornell Cancer Center at Cornell University | |||||
| New York, New York, United States, 10021 | |||||
| Albert Einstein College of Medicine of Yeshiva University |
| National Cancer Institute (NCI) |
| Principal Investigator: | Ruben Niesvizky, MD | Weill Medical College of Cornell University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000316449, AECM-0403765, NCI-5996 |
| First Received: | August 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066638 |
| Health Authority: | United States: Federal Government |
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