Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome

NCT00053001 | Completed Phase 2

• 5 other identifiers: FALLON-PR01-09-010CDR0000258753CELGENE-PR01-09-010ORTHO-PR01-09-010FALLON-757
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anemia; Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical response

Interventions

epoetin alfa BIOLOGICAL

thalidomide DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fallon Clinic: lead

Study Sites (2)

Fallon Clinic at Worcester Medical Center

Worcester, Massachusetts, 01608, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Anemia; Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Myeloproliferative Disorders

Interventions

Epoetin Alfa; Thalidomide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Laszlo Leb, MD

  Fallon Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: June 1, 2001
• Study Completion: October 1, 2007
• Last Updated: June 26, 2013

Record last verified: 2007-10

Locations

US (2)