Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Monoclonal Antibody Therapy Following Chemotherapy in Treating Patients With Relapsed Acute Myeloid Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	over 18	Pharmaceutical / Industry	MDX-93-PM81-1 NCI-V94-0596

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 Contact Information

Trial Lead Organizations

Medarex, Incorporated

Lisa Hammert, MD, Protocol chair(Contact information may not be current)		Ph: 412-623-3205