|
||||||||||||||||||||||
|
|
Phase I/II Study of Adjunctive Therapy with MOAB PM-81 following Re-induction Chemotherapy in Patients with Relapsed Acute Myeloid Leukemia (Summary Last Modified 09/2000)
Alternate Title Monoclonal Antibody Therapy Following Chemotherapy in Treating Patients With Relapsed Acute Myeloid Leukemia
Objectives I. Evaluate the safety of murine monoclonal antibody PM-81 administered as a continuous infusion of 1 mg/kg/day for up to 3 days as adjunctive therapy following re-induction chemotherapy in patients with relapsed acute myeloid leukemia. II. Determine the clearance rate of circulating PM-81. III. Estimate the response rate of patients treated with adjunctive PM-81 after induction chemotherapy. Entry Criteria Disease Characteristics: Relapsed acute myeloid leukemia (AML) Any FAB subclass eligible Secondary AML eligible AML blast cells positive for CD-15, i.e., greater than 20% of leukemic cells positive by immunofluorescence and reactive with PM-81 Prior/Concurrent Therapy: No prior murine monoclonal antibody other than PM-81 Patient Characteristics: Age: Over 18 Performance status: Karnofsky 70-100% Hematopoietic: Not applicable Hepatic: Bilirubin no greater than 1.5 mg/dl SGOT/SGPT no greater than 3 x normal Renal: Creatinine clearance at least 50 ml/hour Cardiovascular: LVEF at least 40% by MUGA Pulmonary: FEV1 at least 65% of predicted DLCO at least 50% of predicted Other: No serious infection No pregnant or nursing women Negative serum beta-HCG required of fertile women within 1 week prior to PM-81 Effective contraception required of fertile women Expected Enrollment At least 25 patients will be accrued over 12 months. Outline Induction regimens are assigned according to remission duration and age: Regimen A: remission duration 1 year or more, age over 60 Regimen B: remission duration 1 year or more, age under 60 Regimen C: remission duration less than 1 year, age over 60 Regimen D: remission duration less than 1 year, age under 60 The following acronyms are used: ARA-C Cytarabine, NSC-63878 DHAD Mitoxantrone, NSC-301739 DNR Daunorubicin, NSC-82152 PM-81 Murine Monoclonal Antibody PM-81 VP-16 Etoposide, NSC-141540 Induction: Regimen A: 2-Drug Combination Chemotherapy. ARA-C; DHAD. Regimen B: 2-Drug Combination Chemotherapy. ARA-C; DNR Regimen C: 2-Drug Combination Chemotherapy. DHAD; VP-16. Regimen D: 2-Drug Combination Chemotherapy. ARA-C; DNR. Regimen E (Post-Induction Adjunctive Therapy): Monoclonal Antibody Therapy. PM-81. Trial Lead Organizations Medarex, Incorporated
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |