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Status:

COMPLETED

3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Myelodysplastic Syndromes

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more cancer cells by m...

Detailed Description

OBJECTIVES: * Determine the feasibility and tolerability of 3-AP (Triapine\^® ) followed by fludarabine in patients with relapsed or refractory acute or chronic leukemia or high-risk myelodysplastic ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of 1 of the following:
  • High-risk myelodysplastic syndromes (MDS), including refractory anemia with excess blasts and chronic myelomonocytic leukemia
  • International Prognostic Scoring System (IPSS) score at least 1.5 based on the following:
  • More than 10% marrow blasts
  • Cytopenias in at least 2 lineages
  • Adverse cytogenetics
  • Acute myeloid leukemia (AML)
  • All subtypes, including MDS/AML and treatment-related (secondary) AML
  • Acute lymphoblastic leukemia
  • Acute progranulocytic leukemia
  • Ineligible for arsenic therapy
  • Chronic myelogenous leukemia
  • Accelerated phase or blastic crisis
  • Chronic lymphocytic leukemia
  • Prolymphocytic leukemia
  • Received or ineligible for established curative regimens, including stem cell transplantation
  • Acute and chronic leukemias must be relapsed and/or refractory with progressive disease since last therapy
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • No history of hemolytic anemia grade 2 or greater
  • No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • G6PD screening required for high-risk groups (i.e., patients of African, Asian, or Mediterranean origin/ancestry)
  • Hepatic
  • SGOT and SGPT no greater than 2.5 times normal
  • Bilirubin no greater than 2 mg/dL
  • No chronic hepatitis
  • Renal
  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min
  • Cardiovascular
  • No active heart disease
  • No myocardial infarction within the past 3 months
  • No severe coronary artery disease
  • No arrhythmias (other than atrial flutter or fibrillation) requiring medication
  • No uncontrolled congestive heart failure
  • Pulmonary
  • No dyspnea at rest or with minimal exertion
  • No severe pulmonary disease requiring supplemental oxygen
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy grade 2 or greater
  • No active uncontrolled infection
  • Infections under active treatment and controlled by antibiotics are allowed
  • No other life-threatening illness
  • No psychiatric illness that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • At least 1 week since prior hematopoietic growth factor (e.g., epoetin alfa, filgrastim \[G-CSF\], sargramostim \[GM-CSF\], interleukin-3, and interleukin-11)
  • No concurrent immunotherapy
  • Chemotherapy
  • Recovered from prior chemotherapy (no greater than grade 1 chronic toxic effects)
  • At least 72 hours since prior hydroxyurea
  • At least 3 weeks since prior myelosuppressive cytotoxic agents (6 weeks for mitomycin or nitrosoureas)
  • No more than 12 prior courses of fludarabine
  • No more than 3 prior cytotoxic chemotherapy regimens
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy
  • Surgery
  • Not specified
  • Other
  • At least 1 week since prior non-myelosuppressive treatment
  • No more than 4 prior induction regimens
  • No other concurrent therapy

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00077558

    Start Date

    January 1 2004

    Last Update

    March 10 2010

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, United States, 30342-4777

    2

    Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, United States, 21201

    3

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231

    4

    M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4095