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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care, Treatment Closed 17 to 55 FHCRC-601.0 NCI-V94-0382

Objectives

I.  Estimate the relapse rate, relapse-free mortality, and disease-free 
survival of patients with acute myeloid leukemia in first or second remission 
or untreated first relapse who undergo marrow ablation with cyclophosphamide 
and total-body irradiation followed by allogeneic bone marrow rescue and who 
receive antitumor necrosis factor therapy with ciprofloxacin and 
pentoxifylline during the peritransplant period.

Entry Criteria

Disease Characteristics:

Acute myeloid leukemia (AML) in first or second remission or in
untreated first relapse

Donor requirements:
  Genotypically HLA-identical sibling
  Relative genotypically identical for 1 haplotype and
     phenotypically identical for the other
  No anesthesia risk
  Age over 65 requires review by Patient Care Committee

Prior/Concurrent Therapy:

Not specified

Patient Characteristics:

Age:
  17 to 55

Performance status:
  Not specified

Life expectancy:
  No severe limitations other than AML

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  SGOT no greater than 100 IU

Renal:
  Creatinine no greater than 2 x normal

Cardiovascular:
  No cardiac condition that precludes cyclophosphamide
     LVEF evaluation required if:
        History of cardiac problems
        History of high-dose anthracyclines

Other:
  No history of cyclophosphamide-induced cystitis

Expected Enrollment

Up to 30 patients will be entered over 3 years.

Outline

The following acronyms are used:
  CPFX      Ciprofloxacin
  CTX       Cyclophosphamide, NSC-26271
  MTX       Methotrexate, NSC-740
  PTX       Pentoxifylline
  TBI       Total-Body Irradiation
  Anti-TNF  Anti-Tumor Necrosis Factor

Anti-TNF Therapy plus Myeloablative Chemoradiotherapy followed by 
Hematopoietic Rescue plus, as indicated, Intrathecal Chemotherapy.  PTX; CPFX; 
plus CTX; TBI using Co60 sources; followed by allogeneic bone marrow; plus, if 
CSF is positive, IT MTX.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Reginald A. Clift, FIMLS, Protocol chair		Ph: 206-667-4325