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.

Condition	Treatment or Intervention	Phase
adult acute differentiated monocytic leukemia (M5b) adult acute myeloblastic leukemia without maturation (M1) adult acute minimally differentiated myeloid leukemia (M0) adult acute poorly differentiated monocytic leukemia (M5a) recurrent adult acute myeloid leukemia adult acute erythroleukemia (M6) adult acute myelomonocytic leukemia (M4) adult acute myeloblastic leukemia with maturation (M2) secondary acute myeloid leukemia adult acute megakaryocytic leukemia (M7)	Drug: monoclonal antibody HuG1-M195	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Christos E. Emmanouilides,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068076; UCLA-9910096; NCI-G00-1823; PDL-195-302
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006084
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08