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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00520468 |
Purpose
Primary Objective:
1. To evaluate the response rate of total cytokine-immunotherapy for low-risk MDS.
Secondary Objective:
1. To evaluate response duration, survival and side effects of the treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome |
Drug: Erythropoietin Drug: Cyclosporin A Drug: G-CSF Drug: Prednisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2004 |
MDS is a disease that produces low blood counts and may cause anemia, infections, and/or bleeding. Erythropoietin and G-CSF are drugs that stimulate the production of red cells and white cells. Prednisone and cyclosporin are drugs that work against MDS by affecting your immune system.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Routine blood tests (between 4-6 tablespoons) will be performed. You will have a bone marrow aspiration. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive erythropoietin as an injection under the skin once a week and G-CSF as an injection under the skin 1-2 times a week for as long as you respond well to treatment. You will take prednisone by mouth every day for a month and cyclosporin tablets by mouth every day for 6 months.
During this study, you will need to visit your doctor for a physical exam and measurement of your vital signs. The frequency of doctor visits will vary depending on your physical condition, but will be required at least once every 3 months.
Blood tests (about 2 teaspoons) will be done about every 1-2 weeks during the first 12 weeks of treatment, then every 2 to 4 weeks for the remainder of the study. The blood samples will be collected for routine lab tests. Periodic (every 3 to 6 months) bone marrow samples will also be taken to check cells related to the disease before, during, and after completion of this study.
You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. All drugs are FDA approved and commercially available. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gautam Borthakur, MD | 713-792-7305 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Gautam Borthakur, MD | |
| Principal Investigator: | Gautam Borthakur, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | 2004-0253 |
| Study First Received: | August 23, 2007 |
| Last Updated: | August 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00520468 |
| Health Authority: | United States: Institutional Review Board |
|
Myelodysplastic Syndrome MDS Erythropoietin |
G-CSF Prednisone Cyclosporin A |
|
Myelodysplastic syndromes Epoetin Alfa Prednisone Cyclosporine Precancerous Conditions Hematologic Diseases Clotrimazole |
Miconazole Myelodysplastic Syndromes Myelodysplasia Tioconazole Cyclosporins Preleukemia Bone Marrow Diseases |
|
Anti-Inflammatory Agents Anti-Infective Agents Disease Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hematinics Hematologic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Hormones Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |
