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Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer Clinical research trials and Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer. Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer  Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer
Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer
For Condition: thorax and respiratory cancer,Head and Neck Cancer,hematopoietic and lymphoid cancer,Breast Cancer
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who have metastatic or unresectablemantle cell lymphoma, squamous cell carcinoma of the head and neck, small cell lung cancer, or invasivestage IV breast cancer.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of flavopiridol in patients with metastatic or unresectable mantle cell lymphoma, squamous cell carcinoma of the head and neck, small cell lung cancer, or invasive breast cancer. Secondary - Determine the safety profile and toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine, by pharmacodynamic assays, the ability of this drug to inhibit cyclin-dependent kinase activity in tumor tissue, normal proliferating tissues, circulating tumor cells, and in plasma in these patients. - Determine, preliminarily, the antitumor activity of short infusions of this drug in these patients. OUTLINE: This is a 2-part, dose-escalation study. - Patients receive flavopiridol IV over 1 hour on days 1, 8, and 15. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD)* is determined. - Patients receive flavopiridol IV over 1 hour at one dose level below the MTD determined in part 1 and then receive a maintenance dose of flavopiridol IV over 1-6 hours on days 1, 8, and 15. Cohorts of 3-6 patients receive escalating durations of the maintenance dose of flavopiridol until the MTD * is determined. NOTE: *The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. In both parts, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 3-80 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy, including the following types: - Mantle cell lymphoma - Morphologically confirmed disease - CD20 and CD5 positive - Squamous cell carcinoma of the head and neck - Metastatic, recurrent, or refractory disease - Small cell lung cancer - Extensive stage or limited stage disease in relapse - Breast cancer - Histologically or cytologically confirmed stage IV invasive disease - Metastatic or unresectable disease for which standard therapy does not exist or is no longer effective - Measurable or nonmeasurable disease - Measurable disease defined as at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques or 10 mm by spiral CT scan - Nonmeasurable disease includes any of the following: - All other lesions, including lesions less than 20 mm by conventional techniques or 10 mm by spiral CT scan - Bone lesions - Cytologically positive pleural or peritoneal disease - Elevated tumor marker (e.g., CEA, CA 125, CA 19-9, or other tumor marker) - Multinodular or confluent nonmeasurable pulmonary, hepatic, adrenal, intra-abdominal, or skin metastases - Previously treated with at least 1 chemotherapy regimen - Prior therapy may have included combined modality treatment (e.g., full-dose chemotherapy and radiotherapy with radiosensitizing chemotherapy) - No active CNS metastases - History of CNS metastases allowed provided all of the following criteria are met: - Previously treated and stable and asymptomatic for at least 4 weeks since the completion of treatment - Image documentation required - Off steroids or on a stable dose of steroids for at least 1 week - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular - No myocardial infarction within the past 6 months - No unstable angina within the past 6 months - No transient ischemic attack or cerebrovascular accident within the past 6 months - No history of arterial vascular events - No new cardiac arrhythmias likely to be related to cardiac ischemia within the past 6 months - No symptomatic congestive heart failure Pulmonary - No history of pulmonary embolism within the past 6 months Gastrointestinal - No chronic diarrheal disease within the past 6 months - No severe malnutrition - No intractable emesis Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No ongoing or active infection - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Prior biologic therapy (e.g., monoclonal antibody therapy, immunologic therapies, epidermal growth factor receptor inhibitors, angiogenesis inhibitors, or other investigational agents) allowed Chemotherapy - See Disease Characteristics - No prior flavopiridol - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to 50% or more of bone marrow Surgery - Not specified Other - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeoffreyShapiro, Principal Investigator, Dana-Farber/Harvard Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Geoffrey Shapiro 617-632-4942
Additional Information:
Study ID Numbers: CDR0000331689; NCI-6052,DFCI-03082
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070239
Other Hematopoietic And Lymphoid Cancer Studies:
1. Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer
2. Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
3. Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
4. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
5. BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Related Studies:
Other hematopoietic and lymphoid cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer
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