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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-IND127 | Other Identifier | PDQ | |
| NCI-100 | Other Identifier | NCI | |
| CDR0000067679 | Other Identifier | PDQ |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alvocidib | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy
CD20 and CD5 positive
Presence of clinically and/or radiologically documented disease
At least 1 site of disease must be bidimensionally measurable
Bone lesions not considered bidimensionally measurable
Minimum indicator lesions must be:
No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
No clinically significant pulmonary symptomatology
If history of symptomatic pulmonary disease:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M. Connors, MD | British Columbia Cancer Agency | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada | ||
| Cancer Care Ontario-Hamilton Regional Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12735303 | Result | Kouroukis CT, Belch A, Crump M, Eisenhauer E, Gascoyne RD, Meyer R, Lohmann R, Lopez P, Powers J, Turner R, Connors JM; National Cancer Institute of Canada Clinical Trials Group. Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003 May 1;21(9):1740-5. doi: 10.1200/JCO.2003.09.057. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C077990 | alvocidib |
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| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Humber River Regional Hospital | Weston | Ontario | M9N 1N8 | Canada |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |