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| Sponsor: | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00997243 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as lintuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying the side effects and how well giving azacitidine together with lintuzumab works in treating patients with previously untreated myelodysplastic syndromes.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Biological: lintuzumab Drug: azacitidine Other: pharmacological study |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of 5-azacytidine and Lintuzumab in Myelodysplastic Syndromes (MDS) |
| Estimated Enrollment: | 35 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive azacitidine IV or subcutaneously once daily on days 1-7 and lintuzumab IV on days 2, 7, 15, and 22 (days 2 and 15 of course 1 only). Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.
Blood and bone marrow samples are collected periodically for pharmacodynamic studies.
After completion of study treatment, patients are followed up for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndromes (MDS) by FAB or WHO criteria (FAB criteria for MDS includes ≤ 29% blasts and chronic myelomonocytic leukemia)
Previously untreated disease
Patients with refractory anemia or refractory anemia with ringed sideroblasts must have significant marrow dysfunction as defined by meeting 1 of the following criteria:
CD33 expression required on ≥ 25% of left-shifted dysplastic myeloid cells, including blasts
PATIENT CHARACTERISTICS:
No uncontrolled concurrent illness including, but not limited to, any of the following:
More than 3 years since prior diagnosis or treatment of another malignancy except for any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent ongoing therapeutic anticoagulation with warfarin, Lovenox, or similar agent
No concurrent ongoing clopidogrel therapy
Contacts and Locations| Principal Investigator: | Alison Walker, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Responsible Party: | Alison Walker, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00997243 History of Changes |
| Other Study ID Numbers: | CDR0000656787, OSU-09034 |
| Study First Received: | October 16, 2009 |
| Last Updated: | February 2, 2010 |
| Health Authority: | Unspecified |
|
de novo myelodysplastic syndromes secondary myelodysplastic syndromes chronic myelomonocytic leukemia refractory anemia with excess blasts in transformation |
refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia refractory cytopenia with multilineage dysplasia |
|
Leukemia Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Azacitidine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |