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Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma Clinical research trials and Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma. Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma clinical trial. Participants frequently get the best healthcare available for their Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma  Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
For Condition: stage 3 mantle cell lymphoma,recurrent mantle cell lymphoma,stage 4 mantle cell lymphoma,stage 2 mantle cell lymphoma,stage 1 mantle cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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.
Details: OBJECTIVES: - Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma. - Assess the toxicity of this regimen in this patient population. - Determine the time to progression and, if responses are observed, response duration in these patients treated with this regimen. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy - No documented disease progression while receiving prior chemotherapy - 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: - Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR - Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam - No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute granulocyte count at least 1,500/mm3 - Platelet count at least 75,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit or normal (ULN) - AST no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No clinically significant cardiac symptomatology - If history of cardiac disease, cardiac ejection fraction greater than 50% Pulmonary: - No clinically significant pulmonary symptomatology - If history of symptomatic pulmonary disease: - FEV1, FVC, and TLC greater than 60% predicted - DLCO greater than 50% predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Must be accessible for treatment and follow-up (i.e., no geographical limitations) - No uncontrolled bacterial, fungal, or viral infection - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior radioactive monoclonal antibody therapy - Prior rituximab allowed Chemotherapy: - See Disease Characteristics - No more than 2 prior chemotherapy regimens allowed - Same chemotherapy combination given for first line and second line therapy considered 2 regimens - At least 6 weeks since prior chemotherapy - No prior high-dose chemotherapy and stem cell transplantation - No other concurrent cytotoxic chemotherapy Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - No prior radiotherapy to greater than 25% of functioning bone marrow - At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered - No concurrent radiotherapy to sole site of measurable disease Surgery: - At least 2 weeks since prior major surgery Other: - No other concurrent investigational anticancer agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephConnors, Study Chair, British Columbia Cancer Agency
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Additional Information:
Study ID Numbers: CDR0000067679; CAN-NCIC-IND127,NCI-100
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005074
Other Recurrent Mantle Cell Lymphoma Studies:
1. Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
2. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma
3. FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma
4. Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
5. Interferon alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non- Hodgkin's Lymphoma
Related Studies:
Other recurrent mantle cell lymphoma Clinical Trials
Other Nova Scotia Clinical Trials
Other Halifax Clinical Trials
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
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