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Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia. Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia clinical trial. Human subjects often get the best healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia  Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
For Condition: recurrent adult acute myeloid leukemia,refractory chronic lymphocytic leukemia,stage 3 diffuse small lymphocytic/marginal zone lymphoma,stage 4 diffuse small lymphocytic/marginal zone lymphoma,noncontiguous stage 2 diffuse small lymphocytic/marginal zone lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent adult acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
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 chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) or biological effective dose of monoclonal antibody Hu1D10 in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. (Patients with acute lymphoblastic leukemia or acute myeloid leukemia are enrolled after the MTD is determined.) - Determine the safety of this drug, in terms of frequency and severity of treatment-related adverse events, in this patient population. - Determine whether this drug has anti-leukemia/lymphoma activity in patients expressing the Hu1D10 antigen. - Determine the pharmacokinetics of this drug in this patient population. - Determine whether the infusion-related toxicity of this drug is secondary to cytokine release in these patients. - Determine whether the intensity of 1D10 target antigen on tumor cells is related to clinical response and treatment toxicity in these patients. - Determine the pharmacodynamics of this drug in this patient population. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (chronic lymphocytic leukemia or small lymphocytic lymphoma vs acute lymphoblastic leukemia [ALL] or acute myeloid leukemia [AML]). Patients with ALL or AML are enrolled after the maximum tolerated dose (MTD) is determined. Patients receive monoclonal antibody Hu1D10 (MOAB Hu1D10) IV over at least 2 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen. Cohorts of 3-6 patients receive escalating doses of MOAB Hu1D10 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT). If no DLT is observed, the biological effective dose (BED) is determined in the above cohorts. The BED is defined as the dose at which at least 4 of 6 patients experience an acceptable minimum trough level and clinical response. An additional 24 patients (12 per stratum) are treated at the MTD. Patients are followed at 1 week, 1 and 2 months, and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 35 patients (12 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous stage II or stage III-IV small lymphocytic lymphoma (SLL) - Previously treated with at least 1 form of chemotherapy or immunotherapy - Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum tolerated dose (MTD) is determined) - Must have failed 1 prior therapy - Ineligible for allogeneic stem cell transplantation - Histologically confirmed acute myeloid leukemia (enrolled after the MTD is determined) - Primary refractory or relapsed (within the past year) disease - Ineligible for potential curative therapy - Express Hu1D10 antigen - Greater than 2 times the mean fluorescence intensity of the control by flow cytometry (blood or bone marrow cells) OR - Positive by immunohistochemical staining (lymph node) - Presenting with one of the following indications for treatment unless early bone marrow transplantation is planned (CLL or SLL patients only): - Disease-related progressive symptoms - Progressively worsening anemia or thrombocytopenia - Progressively worsening lymphadenopathy - Massive splenomegaly or hypersplenism - Hyperlymphocytosis (WBC greater than 200,000/mm3) or lymphocyte doubling time less than 12 months - Marrow failure secondary to marrow infiltration by leukemia or lymphoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 2 years Hematopoietic: - See Disease Characteristics - Platelet count at least 50,000/mm^3 (without transfusion) Hepatic: - Bilirubin no greater than 3 mg/dL (unless elevated secondary to tumor) Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No prior decompensated congestive heart failure, unstable angina, or myocardial infarction within the past 6 months not corrected by percutaneous transluminal coronary angioplasty or surgery Other: - No active infection requiring oral or IV antibiotics - No other malignancy that would limit life expectancy - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 1 month since prior rituximab or alemtuzumab (unless CD20 or CD52 antigen is expressed on tumor cells) - No prior monoclonal antibody Hu1D10 Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnByrd, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: CDR0000068695; OSU-0101,OSU-HU1D10-8308,OSU-00H0230,NCI-1254
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017472
Other Stage 4 Diffuse Small Lymphocytic/marginal Zone Lymphoma Studies:
1. Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
2. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
3. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
4. FR901228 in Treating Patients With Hematologic Cancer
5. Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
Related Studies:
Other stage 4 diffuse small lymphocytic/marginal zone lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
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