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Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma Clinical research trials and Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma. Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma  Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma
Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma
For Condition: Lymphoma,Leukemia,plasma cell neoplasm
Status: No longer recruiting
Sponsor(s): Massey Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the toxic effects and maximum tolerated dose of bryostatin 1 and fludarabine in patients with symptomatic or advanced chronic lymphocytic leukemia or relapsed indolent non-Hodgkin's lymphoma. - Monitor apoptosis, differentiation, and protein kinase C activity in leukemic lymphocytes exposed in vivo to bryostatin 1 and fludarabine. - Observe the antitumor activity of this combination therapy in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to one of two treatment groups. - Group I: Patients receive bryostatin 1 IV over 24 hours followed by fludarabine IV over 30 minutes daily on days 1-5. - Group II: Patients receive fludarabine IV over 30 minutes daily on days 1-5 followed by bryostatin 1 IV over 24 hours. In both groups, courses repeat every 4 weeks for patients with stable or responding disease. Cohorts of 3-6 patients receive escalating doses of fludarabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for fludarabine is determined, the dose of bryostatin 1 is escalated. PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed chronic lymphocytic leukemia - Stage I (symptomatic or with bulky lymphadenopathy) - Stage II, III, or IV - Prior chemotherapy allowed, including fludarabine or other purine nucleoside analog therapy OR - Histologically confirmed indolent non-Hodgkin's lymphoma - Progressive or relapsed following chemotherapy - Includes the following histologies: - B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/lymphomas - Lymphoplasmacytoid lymphoma (Waldenstrom's)/immunocytoma - Mantle cell lymphoma - Follicular lymphoma - Small cell - Mixed small and large cell - Diffuse (predominately small cell type) - Marginal zone B-cell lymphoma - Extranodal (MALT-type with or without monocytoid B-cells) - Provisional subtype: nodal (with or without monocytoid B-cells) - Provisional entity: splenic marginal zone lymphoma (with or without villous lymphocytes) - Hairy cell leukemia - Peripheral T-cell and NK-cell neoplasms - T-cell chronic lymphocytic leukemia/polylymphocytic leukemia - Large granular lymphocyte leukemia - T-cell type - NK-cell type - Mycosis fungoides/Sezary's syndrome (cutaneous T-cell lymphoma) - No CNS disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,000/mm3 - Platelet count at least 75,000/mm3 - Hemoglobin at least 8 g/dL - Coombs negative Hepatic: - AST/ALT no greater than 2.5 times upper limit of normal - Bilirubin no greater than 2 mg/mL Renal: - Creatinine clearance at least 40 mL/min Other: - No concurrent neurologic condition - No other concurrent medical condition that would preclude study - Not pregnant or nursing - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent systemic immunoglobulin therapy - No prior bone marrow or peripheral stem cell transplantation Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior systemic chemotherapy Endocrine therapy: - No concurrent systemic glucocorticoid therapy Radiotherapy: - Not specified Surgery: - Not specified Other: - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenGrant, Study Chair, Massey Cancer Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000066433; MCV-CCHR-9801-2C,NCI-T97-0116
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005580
Other Leukemia Studies:
1. Autologous Platelets
2. Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
3. Pegfilgrastim PBPC Mobilization Study
4. Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma
5. Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
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Bryostatin 1 Plus Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma
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