Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome
This study has been completed.
Sponsor:
Fallon Clinic
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053001
First received: January 27, 2003
Last updated: May 14, 2011
Last verified: October 2007
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Purpose
RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve anemia, decrease the need for blood transfusions, and improve the quality of life in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa in treating anemia in patients who have myelodysplastic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms |
Biological: epoetin alfa Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Phase II Study on the Effectiveness of Thalomid (Thalidomide) Combined With Procrit (Erythropoietin) for the Treatment of Anemia in Patients With Low and Intermediate Risk-1 (IPSS Score Less Than or Equal to 1.5) Myelodysplastic Syndromes |
Resource links provided by NLM:
MedlinePlus related topics:
Anemia
Cancer
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Clinical response
| Study Start Date: | June 2001 |
OBJECTIVES:
- Determine whether the combination of epoetin alfa and thalidomide improves the anemia and/or decreases the need for red cell transfusion in patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine whether this regimen improves the bone marrow morphology and cytogenetics, alters the natural history of the disease, and reduces the frequency of leukemic transformation in these patients.
- Evaluate whether this regimen improves pathophysiologic parameters (e.g., apoptosis, tumor necrosis factor-alpha concentration, microvessel density, vascular endothelial growth factor, and cytotoxic T lymphocytes) in the bone marrow of these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive epoetin alfa subcutaneously (SC) once weekly for 8 weeks. After 8 weeks, patients unresponsive to epoetin alfa alone receive oral thalidomide once daily in addition to epoetin alfa SC once weekly for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 2 years..
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndromes
- Newly diagnosed OR
- Prior treatment was unsuccessful, including treatment with chemotherapy
- International prognostic scoring system score no greater than 1.5
- Hemoglobin no greater than 10 g/dL (untransfused) AND/OR
- Received at least 3 units of packed red blood cells for symptomatic anemia within the past 6 weeks
PATIENT CHARACTERISTICS:
Age
- Over 21
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 6 months
Hematopoietic
- See Disease Characteristics
- No prior bleeding disorder
Hepatic
- Bilirubin less than 2 mg/dL
- ALT/AST less than 2 times upper limit of normal
Renal
- Creatinine less than 1.5 mg/dL
Cardiovascular
- No prior clinically significant heart disease
- No uncontrolled hypertension
No recent thromboembolic disease (e.g., deep vein thrombosis)
- Prior thromboembolic events allowed provided event occurred at least 6 weeks prior to study and patient is on anticoagulants and is clinically stable
Pulmonary
- No unstable pulmonary disease
- No recent pulmonary embolism
- No active pulmonary infection
Neurologic
- No pre-existing peripheral neuropathy greater than grade 2
- No sustained neurologic deficit
- No epilepsy
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods (including 1 highly effective method) of contraception for at least 4 weeks before, during, and for at least 4 weeks after study completion
- No active infection
- No concurrent illness that would obscure toxicity or dangerously alter drug metabolism
- No other serious concurrent medical illness
- No uncontrolled diabetes mellitus
- No other malignant disease (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off therapy for that disease for more than 1 year
- No known hypersensitivity to mammalian cell-derived products or human albumin
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 4-6 weeks since prior therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053001
Locations
| United States, Massachusetts | |
| Fallon Clinic at Worcester Medical Center | |
| Worcester, Massachusetts, United States, 01608 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
Sponsors and Collaborators
Fallon Clinic
Investigators
| Study Chair: | Laszlo Leb, MD | Fallon Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00053001 History of Changes |
| Other Study ID Numbers: | CDR0000258753, FALLON-PR01-09-010, CELGENE-PR01-09-010, ORTHO-PR01-09-010, FALLON-757 |
| Study First Received: | January 27, 2003 |
| Last Updated: | May 14, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
de novo myelodysplastic syndromes secondary myelodysplastic syndromes previously treated myelodysplastic syndromes anemia |
atypical chronic myeloid leukemia, BCR-ABL1 negative myelodysplastic/myeloproliferative neoplasm, unclassifiable childhood myelodysplastic syndromes |
Additional relevant MeSH terms:
|
Anemia Neoplasms Leukemia Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Hematologic Diseases Neoplasms by Histologic Type Bone Marrow Diseases Precancerous Conditions Epoetin Alfa Thalidomide Hematinics |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013