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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 to 60 MSKCC-94019 NCI-V94-0499

Objectives

I.  Estimate the maximum tolerated concentration of benzoporphyrin derivative 
monoacid ring A (BPD-MA) for bone marrow purging by assessing engraftment 
following autologous bone marrow transplantation in patients with acute 
lymphocytic or myeloid leukemia in second complete remission.

Entry Criteria

Disease Characteristics:

Clinical and laboratory diagnosis of acute lymphocytic leukemia
(ALL) or acute myeloid leukemia (AML) in second complete
remission
  Bone marrow evaluation required within 7 days of harvest
  Sufficient marrow cellularity for harvest required

No histocompatible sibling donor unless allogeneic bone marrow
transplant is contraindicated

Prior/Concurrent Therapy:

No concurrent enrollment on a clinical trial requiring
experimental medication

No concurrent requirement for medication that would affect
engraftment

Patient Characteristics:

Age:
  18 to 60

Performance status:
  Karnofsky 70-100% (ECOG 0-1)

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000
  Hb at least 10 g/dl

Hepatic:
  Bilirubin no greater than 2 x ULN
  SGOT/SGPT no greater than 2 x ULN
  No coagulopathy

Renal:
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  LVEF at least 45% on MUGA
  No history of cardiac disease requiring active therapy:
     No CHF
     No dysrhythmia
     No angina
  No uncontrolled hypertension

Pulmonary:
  DLCO and ABG at least 50% of predicted
  Chest x-ray normal
  Other pulmonary function tests normal

Other:
  Not HIV seropositive
  No active infection
  No uncontrolled diabetes
  No hypersensitivity to components of test drug
  No active photosensitive disease, including:
     Porphyria
     Systemic lupus erythematosus
  No concomitant condition that could affect patient assessment
  No history of unreliability or noncompliance with therapy
  No pregnant or nursing women
  Adequate contraception required of fertile women

Expected Enrollment

21 patients will be entered on this 2-center study.

Outline

The following acronyms are used:
  ABM      Autologous Bone Marrow
  ALLO     Allopurinol
  BPD-MA   Benzoporphyrin Derivative Monoacid Ring A
  BU       Busulfan, NSC-750
  CTX      Cyclophosphamide, NSC-26271
  TMP-SMX  Trimethoprim/sulfamethoxazole

2-Drug Marrow-Ablative Chemotherapy followed by Autologous Bone Marrow 
Transplantation.  BU; CTX; followed by ABM, purged with BPD-MA.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Stephen Nimer, MD, Protocol chair		Ph: 212-639-7871; 800-525-2225