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Home > "M" Clinical Trials Conditions > Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia  Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
For Condition: secondary acute myeloid leukemia,adult acute minimally differentiated myeloid leukemia (M0),recurrent adult acute myeloid leukemia,adult acute differentiated monocytic leukemia (M5b),adult acute myeloblastic leukemia with maturation (M2),adult acute myelomonocytic leukemia (M4),adult acute myeloblastic leukemia without maturation (M1),adult acute poorly differentiated monocytic leukemia (M5a),adult acute megakaryocytic leukemia (M7),adult acute erythroleukemia (M6)
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating patients who have acute myelogenous leukemia that did not respond to standard treatment given in clinical trial PDL 195-301.
Details: OBJECTIVES: I. Determine the safety and efficacy of monoclonal antibody HuG1-M195 as demonstrated by frequency of complete remission (CR) in patients with acute myelogenous leukemia with regimen failure on the control arm of PDL Study 195-301. II. Determine additional evidence of clinical benefit of this treatment as demonstrated by frequency of partial remission (PR), durations of CR and PR, and progression free and overall survival in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 1-4 every 2 weeks for 4 courses. Patients without disease progression after completion of course 4 continue to receive MOAB HuM195 as above. Treatment repeats every month for a maximum of 8 additional courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven acute myelogenous leukemia (AML) with documented regimen failure on the control arm (standard chemotherapy alone) of PDL study 195-301; Regimen failure, defined as: Bone marrow blasts greater than 10% and rising (according to 2 sequential bone marrow samples obtained 1-2 weeks apart) OR Bone marrow blasts greater than 20%; Must enroll within 2 weeks after documented regimen failure - No active CNS leukemia --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy, including bone marrow transplantation, for AML after termination from PDL Study 195-301; No other concurrent biologic therapy for AML - Chemotherapy: See Disease Characteristics; No additional chemotherapy for AML after termination from PDL Study 195-301; No concurrent chemotherapy for AML - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy for AML after termination from PDL Study 195-301; No concurrent radiotherapy for AML - Surgery: Not specified - Other: No other concurrent experimental therapy for AML --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration); SGOT and SGPT no greater than 4 times upper limit of normal (unless related to AML) - Renal: Creatinine less than 2.0 mg/dL (unless related to AML) - Cardiovascular: Left ventricular function normal; No significant cardiovascular disease (e.g., unstable cardiac arrhythmias or unstable angina pectoris); No myocardial infarction within the past 6 months; No New York Heart Association class III or IV heart disease; No active ischemia by EKG - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; No active serious infection not controlled by antimicrobial therapy; No other active malignancy requiring therapy; Medically stable; No significant organ dysfunction
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristosEmmanouilides, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068076; PDL-195-302,NCI-G00-1823,UCLA-9910096
Study Start Date: February 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006084
Other Secondary Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
2. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
3. Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia
4. Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
5. Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia
Related Studies:
Other secondary acute myeloid leukemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
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