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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 15 and over NCI UARK-92016 NCI-T92-0173O, T92-0173

Objectives

I.  Determine the toxicity of 10 days of intravenous tiazofurin (TCAR) 
followed by prolonged maintenance with oral ribavirin in patients with a 
myeloid blast crisis of chronic myeloid leukemia.

II.  Determine whether 2 days of high-dose TCAR followed by 8 days of 
lower-dose TCAR yields a biochemical and hematologic response in these 
patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed chronic myelogenous leukemia in
nonlymphoid blast crisis
  Blast crisis defined as at least 20% blasts or 30% blasts
  plus promyelocytes on peripheral blood or bone marrow
  examination

  Nonlymphoid character of disease progression confirmed by
  absence of Tdt or CALLA on immunologic examination

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior tiazofurin
  More than 3 days since oral chemotherapeutic agents, e.g.,
     hydroxyurea or 6-thioguanine 
  Recovery from prior chemotherapy required
  No concurrent chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No concurrent palliative radiotherapy (other than whole-brain
  radiotherapy)

Surgery:
  Not specified

Patient Characteristics:

Age:
  15 and over

Performance status:
  Karnofsky 60-100%

Life expectancy:
  At least 4 months

Hematopoietic:
  Not applicable

Hepatic:
  Bilirubin no more than 2.0 mg/dl
  Transaminases less than 4 x ULN

Renal:
  Creatinine less than 1.6 mg/dl

Cardiovascular:
  No history of significant cardiac disease

Other:
  No history of significant neurologic disease
  No pregnant or nursing women (negative pregnancy test
     required at entry)
  Adequate contraception required of fertile patients

Expected Enrollment

Up to 25 patients will be entered.  If none of the first 14 patients can be 
maintained on ribavirin, the study will be closed.

Outline

Nonrandomized study.

Induction:  Single-Agent Chemotherapy with Chemosensitization.  Tiazofurin, 
TCAR, NSC-286193; with Allopurinol, ALLO, NSC-1390.

Maintenance:  Single-Agent Chemotherapy with Chemosensitization.  Ribavirin, 
NSC-163039; with ALLO.

Trial Contact Information

Trial Lead Organizations

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Guido Tricot, MD, PhD, Protocol chair		Ph: 501-686-8250 Email: Tricotguidoj@uams.edu