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Status:

COMPLETED

Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Myelodysplastic Syndromes

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Vatalanib may be effective in preventing the development of leukemia in patients who have myelodysplastic syndromes. PURPOSE: This phase II trial is studying vatalanib to see how well it w...

Detailed Description

OBJECTIVES: Primary * Determine the response rate, in terms of hematologic improvement and complete and partial remission, in patients with primary or secondary (therapy-related) myelodysplastic syn...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of primary or secondary (therapy-related) myelodysplastic syndromes\* (MDS), including the following cellular types:
  • Refractory anemia (RA)\*\*
  • RA with excess blasts (RAEB)-1
  • RA with ringed sideroblasts\*\*
  • Refractory cytopenia with multilineage dysplasia
  • Refractory cytopenia with multilineage dysplasia with ringed sideroblasts\*
  • MDS-unclassified\*\*
  • MDS associated with isolated del (5q)\*\*
  • Chronic myelomonocytic leukemia (CMML)-1 NOTE: \*High-risk MDS (i.e., RAEB-2 or CMML-2) is closed to accrual as of 11/30/06
  • NOTE: \*\*Accompanied with at least 1 of the following laboratory values: hemoglobin less than 10 g/dL, platelet count less than 50,000/mm3, or absolute neutrophil count less than 1,000/mm3
  • No prior leukemia (i.e., 20% or greater blasts)
  • No prior primary or metastatic brain tumor or carcinomatous meningitis
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • Hepatic
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • APTT no greater than 1.5 times ULN
  • INR no greater than 1.5
  • Renal
  • Creatinine no greater than 1.5 times ULN
  • Urine protein negative by urinalysis
  • Protein 1+ by dipstick allowed provided total urine protein no greater than 500 mg AND creatinine clearance at least 50 mL/min by 24-hour urine collection
  • Cardiovascular
  • No significant cardiac or vascular events within the past 6 months, including any of the following:
  • Acute myocardial infarction
  • Unstable angina
  • Uncontrolled hypertension
  • Severe peripheral vascular disease (e.g., ischemic pain at rest or nonhealing ulcers or wounds)
  • New York Heart Association class II-IV congestive heart failure
  • Cardiac arrhythmia
  • Disseminated intravascular coagulation or other coagulopathies
  • Deep vein or arterial thrombosis
  • No history of congenital long QTc syndrome or elongated QTc (\> 450 msec for males or 470 for females)
  • Pulmonary
  • No pulmonary embolism within the past 6 months
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
  • No need for full anticoagulation within the past 6 months
  • No significant hemorrhage (e.g., visceral, gastrointestinal, genitourinary, or gynecological) requiring red blood cell transfusion within the past month
  • No known cerebral aneurysms, other cerebrovascular malformations, or CNS bleeding
  • No unhealed fractures, wounds, or ulcers
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 12 months since prior autologous stem cell or allogeneic transplantation
  • More than 6 months since prior antiangiogenic agents
  • More than 1 month since prior interferon for MDS
  • More than 1 month since prior hematopoietic growth factors for MDS
  • More than 1 month since prior epoetin alfa (EPO) for MDS
  • More than 1 month since prior thalidomide for MDS
  • More than 1 month since prior immunotherapy for MDS
  • No concurrent prophylactic growth factors or cytokines (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], EPO or EPO-derivatives, or interleukin-11)
  • Chemotherapy
  • No prior low-dose antimetabolites for MDS (e.g., hydroxyurea, azacitidine, or low-dose cytarabine)
  • More than 12 months since prior chemotherapy for another disease\* NOTE: \*Not MDS or leukemia
  • Endocrine therapy
  • More than 1 month since prior corticosteroids for MDS
  • More than 1 month since prior androgens for MDS
  • Radiotherapy
  • More than 12 months since prior radiotherapy for another disease\* NOTE: \*Not MDS or leukemia
  • Surgery
  • More than 1 month since prior surgery, including needle biopsy of visceral organs and recovered
  • Bone marrow biopsy allowed
  • More than 2 weeks since prior placement of a subcutaneous or tunneled venous access device (e.g., PortaCath or Hickman's catheter) and adequately healed
  • Other
  • No prior cytotoxic therapy for MDS
  • More than 1 month since prior administration of any of the following medications for MDS:
  • Danazol
  • Retinoids
  • Amifostine
  • Investigational agents
  • No concurrent administration of any of the following medications:
  • Warfarin
  • Heparin
  • Derivatives of heparin
  • Other anticoagulants
  • No concurrent grapefruit or grapefruit juice

Exclusion

    Key Trial Info

    Start Date :

    December 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2014

    Estimated Enrollment :

    155 Patients enrolled

    Trial Details

    Trial ID

    NCT00072475

    Start Date

    December 1 2003

    End Date

    June 1 2014

    Last Update

    August 1 2016

    Active Locations (68)

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

    Page 1 of 17 (68 locations)

    1

    Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, United States, 19958

    2

    CCOP - Christiana Care Health Services

    Newark, Delaware, United States, 19713

    3

    Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, United States, 33308

    4

    Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, United States, 33458