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Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia Clinical research trials and Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia  Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
For Condition: stage 4 chronic lymphocytic leukemia,stage 2 chronic lymphocytic leukemia,stage 3 chronic lymphocytic leukemia,refractory chronic lymphocytic leukemia,stage 1 chronic lymphocytic leukemia
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining bryostatin 1 with cladribine in treating patients who have relapsedchronic lymphocytic leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of cladribine when administered after bryostatin 1 in patients with relapsed chronic lymphocytic leukemia. - Determine the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of cladribine. Patients receive bryostatin 1 IV continuously on days 1-3 immediately followed by cladribine IV continuously on days 4-8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Cohorts of 3-6 patients receive escalating dose levels of cladribine 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. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of relapsed chronic lymphocytic leukemia - Intermediate- or high-risk (stage I-IV) disease - Intermediate-risk patients must have active disease, defined by at least 1 of the following criteria: - Presence of any 1 of the following disease-related B symptoms: - 10% or more loss of body weight within the past 6 months - Extreme fatigue - Fever greater than 100 degrees Fahrenheit without evidence of infection - Night sweats - Massive (greater than 6 cm below left costal margin) or progressive splenomegaly - Massive (greater than 10 cm in longest diameter) or progressive lymphadenopathy - Progressive lymphocytosis with an increase of more than 50% over a 2-month period or anticipated doubling time of less than 12 months - Progressive bone marrow failure as manifested by the development or worsening of anemia and/or thrombocytopenia - Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids - Failed 1-2 prior front-line regimens - Failed prior fludarabine - Ineligible for any known treatment of higher potential efficacy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - Transaminases less than 2.5 times normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No history of severe coronary artery disease, cardiomyopathy, uncontrolled congestive heart failure, or arrhythmias Neurologic: - No prior drug-related neurotoxicity - No other neurologic disorder Other: - Not pregnant or nursing - Fertile patients must use effective barrier or non-hormonal contraception during and for 2 months after study participation - No HIV infection - No AIDS PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bone marrow transplantation Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: - See Disease Characteristics - No concurrent steroids - No concurrent hormonal contraceptives Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No other concurrent therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AyadAl-Katib, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Ayad Al-Katib 313-745-8217
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Muhammad Shurafa 313-916-1901
St. John Hospital and Medical Center *Recruiting*
Detroit, Michigan, 48236
United States
Recruiting Ayad Al-Katib 313-343-4000
Additional Information:
Study ID Numbers: CDR0000065984; WSU-C-1388,NCI-T97-0016
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003174
Other Stage 2 Chronic Lymphocytic Leukemia Studies:
1. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
2. Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
3. LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
4. Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
5. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other stage 2 chronic lymphocytic leukemia Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
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