Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center |
---|---|
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00271804 |
The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndrome |
Drug: bortezomib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia |
Estimated Enrollment: | 28 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | April 2007 |
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.
This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia. Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3 cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will start within 2 weeks of completion of the previous cycle. Disease response will be evaluated after cycle 3 and 6.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Karen Ballen, M | Massachusetts General Hospital, Harvard University |
Responsible Party: | Massachusetts general Hospital ( Karen Ballen ) |
Study ID Numbers: | 04-381 |
Study First Received: | December 30, 2005 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00271804 |
Health Authority: | United States: Food and Drug Administration |
Myelodysplastic syndrome Myelodysplasia MDS |
Velcade Thalidomide Bortezomib |
Neural Tube Defects Myelodysplastic syndromes Precancerous Conditions Thalidomide Hematologic Diseases Nervous System Malformations Myelodysplastic Syndromes |
Myelodysplasia Bortezomib Preleukemia Neural tube defect, folate-sensitive Bone Marrow Diseases Congenital Abnormalities |
Anti-Infective Agents Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Protease Inhibitors Anti-Bacterial Agents Neoplasms Pathologic Processes Syndrome Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |