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Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's 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 Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's 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 Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's 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 Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma clinical trial. Participants frequently get the best healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's 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 > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma  Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
For Condition: recurrent adult diffuse large cell lymphoma,recurrent childhood lymphoblastic lymphoma,recurrent childhood large cell lymphoma,recurrent adult lymphoblastic lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent grade II follicular mixed cell lymphoma,recurrent childhood small noncleaved cell lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult diffuse small cleaved cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult acute lymphoblastic leukemia,recurrent grade I follicular small cleaved cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): Parker Hughes Institute ,
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of B43-genistein immunoconjugate in patients with recurrent B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma. II. Determine the systemic B43-genistein exposure levels in these patients. III. Determine the antileukemic activity of this regimen in these patients. IV. Monitor the development of human antimouse antibody in these patients on this regimen. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive B43-genistein immunoconjugate IV over 1 hour on days 1-3, 8-10, and 15-17. Treatment continues every 3 weeks in the absence of unacceptable toxicity or until disease progression. Cohorts of 3-6 patients receive escalating doses of B43-genistein immunoconjugate 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 every 6 months. PROJECTED ACCRUAL: A minimum of 3-15 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Immunophenotypically proven B-cell acute lymphoblastic leukemia; Relapsed at least once following standard induction chemotherapy M1, M2, M3; No CNS disease (including clinical signs of CNS disease) OR Immunophenotypically proven B-cell non-Hodgkin's lymphoma; Refractory or resistant disease following up to 3 prior courses of combination chemotherapy; Relapsed following bone marrow transplantation; No CNS disease; No AIDS-related or HTLV-1 associated lymphomas - NHL must be one of the following types: Small lymphocytic lymphoma (consistent with chronic lymphoblastic leukemia); Follicular small cleaved cell lymphoma; Follicular mixed cell lymphoma; Follicular large cell lymphoma; Diffuse small cleaved cell lymphoma; Diffuse mixed cell lymphoma; Diffuse large cell lymphoma; Immunoblastic large cell lymphoma; Diffuse small noncleaved cell lymphoma - Must have greater than 20% CD19 antigen positive blasts in the bone marrow, peripheral blood, or biopsy (for NHL) at first diagnosis or relapse (non-T cell ALL with CD19 positivity pending allowed) - Patients who have relapsed after bone marrow transplantation are eligible (no active acute or chronic graft versus host disease involving more than the skin) --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; Recovered from prior biologic therapy - Chemotherapy: See Disease Charactertistics; At least 2 weeks since prior chemotherapy (4 weeks since nitrosoureas) and recovered - Endocrine therapy: At least 1 week since prior high dose steroid therapy and recovered - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 80 and under - Performance status: Karnofsky 60-100%; Zubrod 0-2 - Life expectancy: At least 2 months - Hematopoietic: Granulocytopenia, anemia, and/or thrombocytopenia allowed - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT less than 2.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance or radioisotope GFR at least 70 mL/min - Cardiovascular: Shortening fraction at least 27% by echocardiogram OR Cardiac ejection fraction greater than 50% by echocardiogram or gaited radionuclide - Pulmonary: No dyspnea at rest No exercise intolerance; No clinical evidence of significant restrictive pulmonary disease; Pulse oximetry greater than 94%; FEV1 or FVC greater than 60% DLCO at least 65 - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 2 months after study; HIV negative; No uncontrolled diabetes mellitus; No other serious uncontrolled medical condition; No active uncontrolled infection requiring systemic antibiotics or antifungal medications; Prior CNS toxicity no greater than grade 1
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FatihUckun, Study Chair, Parker Hughes Institute
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Parker Hughes Institute
St. Paul, Minnesota, 55113
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Additional Information:
Study ID Numbers: CDR0000067509; HUGHES-PHBC-18,NCI-V00-1583,HUGHES-IRB-9810018
Study Start Date: March 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004858
Other Recurrent Adult Lymphoblastic Lymphoma Studies:
1. Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
2. 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
3. 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
4. FR901228 in Treating Patients With Hematologic Cancer
5. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
Related Studies:
Other recurrent adult lymphoblastic lymphoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
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