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)
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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