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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072475 |
Purpose
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 works in treating patients with primary or secondary myelodysplastic syndromes.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: vatalanib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor (PTK787/ZK222584) (IND #66370, NSC #719335) in Myelodysplastic Syndrome (MDS) |
| Estimated Enrollment: | 144 |
| Study Start Date: | December 2003 |
| Estimated Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified* according to risk group (low grade [refractory anemia with or without ringed sideroblasts, refractory anemia with excess blasts-1, refractory cytopenia with multilineage dysplasia with or without ringed sideroblasts, myelodysplastic syndromes-unclassified, or chronic myelomonocytic leukemia-1] vs high grade [refractory anemia with excess blasts-2 or chronic myelomonocytic leukemia-2]).
NOTE: *Stratification according to risk (low vs high) does not occur after 11/30/06.
Patients receive oral vatalanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with a complete response (CR) receive 6 additional courses after documentation of a CR.
Patients are followed periodically for up to 5 years from study entry.
PROJECTED ACCRUAL: Approximately 144 patients will be accrued for this study within 2.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary or secondary (therapy-related) myelodysplastic syndromes* (MDS), including the following cellular types:
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
Must be registered on CALGB-8461 and CALGB-9665
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Urine protein negative by urinalysis
Cardiovascular
No significant cardiac or vascular events within the past 6 months, including any of the following:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
More than 1 month since prior surgery, including needle biopsy of visceral organs and recovered
Other
More than 1 month since prior administration of any of the following medications for MDS:
No concurrent administration of any of the following medications:
Contacts and Locations
Show 68 Study Locations| Study Chair: | Pankaj Gupta, MD | Veterans Affairs Medical Center - Minneapolis |
More Information
| Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
| Study ID Numbers: | CDR0000339810, CALGB-10105 |
| Study First Received: | November 4, 2003 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00072475 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory cytopenia with multilineage dysplasia chronic myelomonocytic leukemia de novo myelodysplastic syndromes |
secondary myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable refractory anemia previously treated myelodysplastic syndromes |
|
Chronic Myelomonocytic Leukemia Precancerous Conditions Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Anemia Myeloproliferative Disorders Tyrosine Protein Kinase Inhibitors Vatalanib |
Refractory Anemia Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Anemia, Refractory, with Excess of Blasts Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Myelodysplastic Myeloproliferative Disease |
|
Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Vatalanib Leukemia Preleukemia Neoplasms Pathologic Processes Syndrome Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |