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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005074 |
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 previously untreated or relapsed mantle cell lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: alvocidib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after documented CR. Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage. Patients with stable disease receive a maximum of 4 courses.
Patients are followed at 4 weeks and then every 3 months until relapse or death.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy
At least 1 site of disease must be bidimensionally measurable
Minimum indicator lesions must be:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
If history of symptomatic pulmonary disease:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Cancer Care Ontario-Hamilton Regional Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Humber River Regional Hospital | |
Weston, Ontario, Canada, M9N 1N8 | |
Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 |
Study Chair: | Joseph M. Connors, MD | British Columbia Cancer Agency |
Study ID Numbers: | CDR0000067679, CAN-NCIC-IND127, NCI-100 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005074 |
Health Authority: | United States: Federal Government |
stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma stage II mantle cell lymphoma |
Flavopiridol Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin |
Lymphoproliferative Disorders Mantle cell lymphoma Lymphoma Recurrence |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Growth Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |