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Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Clinical research trials and Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia. Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia clinical trial. Test subjects typically obtain the finest healthcare available for their Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia  Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
For Condition: stage 3 chronic lymphocytic leukemia,stage 1 chronic lymphocytic leukemia,stage 2 chronic lymphocytic leukemia,refractory chronic lymphocytic leukemia,stage 4 chronic lymphocytic leukemia
Status: No longer recruiting
Sponsor(s): Genta ,
Synopsis: RATIONALE: Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of chronic lymphocytic leukemia. PURPOSE: Phase I/II trial to study the effectiveness of oblimersen in treating patients who have relapsed or refractory chronic lymphocytic leukemia.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of oblimersen in patients with relapsed or refractory chronic lymphocytic leukemia. II. Determine the safety and efficacy of this drug in these patients. III. Determine the pharmacokinetics and biokinetics of this drug in these patients. PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients receive oblimersen IV continuously on days 1-5. At approximately 3 weeks after the initial dose, patients receive oblimersen IV continuously on days 1-7. Treatment repeats every 3 weeks for up to 4 additional courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 month and then every 2 months for 2 years. PROJECTED ACCRUAL: A total of 6-49 patients (6-24 for phase I and 14-25 for phase II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: This trial is being conducted at many institutions throughout the country. Please contact Genta for a site near you. --Disease Characteristics-- Diagnosis of relapsed or refractory symptomatic chronic lymphocytic leukemia (CLL) requiring therapy Previously treated with at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) Rai stage I-IV - Intermediate-risk must include at least 1 of the following for active disease: *Massive or progressive splenomegaly and/or lymphadenopathy (Spleen tip more than 6 cm below costal margin) *Weight loss of more than 10% within the past 6 months *NCI Common Toxicity Criteria grade 2 or 3 fatigue *Fevers greater than 100.5 degrees F or night sweats for more than 2 weeks (without evidence of infection) *Progressive lymphocytosis with an increase of more than 50% over 2 months or an anticipated doubling time of less than 6 months *Worsening anemia or thrombocytopenia Measurable disease - Absolute lymphocytosis greater than 5,000/mm3 - Lymphocytosis comprising small to moderate size lymphocytes, with fewer than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically determined by manual differential - Bone marrow aspirate smear with more than 30% nucleated lymphoid cells or bone marrow core biopsy with lymphoid infiltrates compatible with CLL - Normocellular or hypercellular bone marrow - Lymphocyte immunophenotype with a predominant B-cell monoclonal population No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of CLL (e.g., myelodysplasia) --Prior/Concurrent Therapy-- Biologic therapy: - At least 3 weeks since prior immunotherapy for CLL and recovered - At least 3 weeks since prior cytokine, biologic, or vaccine therapy for CLL and recovered - No prior autologous or allogeneic stem cell transplantation - Concurrent filgrastim (G-CSF) or epoetin alfa allowed Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent corticosteroid therapy Radiotherapy: At least 3 weeks since prior radiotherapy for CLL and recovered Surgery: - At least 3 weeks since prior major surgery and recovered - No prior organ allograft Other: - At least 3 weeks since other prior therapy for CLL and recovered - No prior hemodialysis - No concurrent immunosuppressive drugs - No other concurrent investigational therapy - No concurrent therapeutic anticoagulation --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm3* - Platelet count at least 50,000/mm3* - Negative Coomb's test - No history of autoimmune thrombocytopenia - No history of hemolytic anemia - No bleeding or coagulation disorder [Note: * Hematopoietic growth factor or transfusion independent] Hepatic: - Bilirubin less than 2 mg/dL - AST less than 1.5 times upper limit of normal (ULN) (5 times ULN if due to CLL) - Albumin at least 3.0 g/dL - PT/PTT no greater than 1.5 times ULN OR - INR less than 1.3 - No chronic hepatitis or cirrhosis Renal: Creatinine less than 2.0 mg/dL Cardiovascular: - No active symptomatic coronary artery disease (e.g., uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication) - No New York Heart Association class III or IV heart disease - No cardiovascular signs or symptoms grade 2 or greater within the past 4 weeks - No uncontrolled congestive heart failure Other: - HIV negative - No other medical disease that would preclude study - No uncontrolled seizure disorder - No uncontrolled serious infection - No known hypersensitivity to phosphorothioate-containing oligonucleotides - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StanleyFrankel, Study Chair, Genta
Genta, Incorporated
New Hyde Park, New York, 11040
United States
Genta, Incorporated
San Antonio, Texas, 78229
United States
Genta, Incorporated
Dallas, Texas, 75246
United States
Genta, Incorporated
Houston, Texas, 77030
United States
Genta, Incorporated
Columbus, Ohio, 43212
United States
Additional Information:
Study ID Numbers: CDR0000068758; MDA-ID-00337,GENTA-GL208
Study Start Date: January 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021190
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
2. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
3. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
4. FR901228 in Treating Patients With Hematologic Cancer
5. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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