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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047203 |
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 flavopiridol in treating patients who have relapsed or refractory multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: alvocidib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma |
Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study within approximately 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment
Durie-Salmon stage I or greater at diagnosis
Must have received at least 1, but no more than 5 prior therapy regimens
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent corticosteroids (including as antiemetics) except chronic corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or adrenal insufficiency)
Radiotherapy
Surgery
Other
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, District of Columbia | |
Howard University College of Medicine | |
Washington, District of Columbia, United States, 20059 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Maryland | |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-5256 |
Study Chair: | Angela Dispenzieri, MD | Mayo Clinic |
Study ID Numbers: | CDR0000257567, MAYO-MC018B, NCI-5758 |
Study First Received: | October 3, 2002 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00047203 |
Health Authority: | United States: Federal Government |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Flavopiridol Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Cardiovascular Diseases Growth Inhibitors |