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

Sponsor

Fallon Clinic (Industry)

Overall Status

Completed

CT.gov ID

NCT00053001

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms	Biological: epoetin alfa Drug: thalidomide	Phase 2

Detailed Description

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..

Study Design

Study Type:

Interventional

Masking:

None (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

Study Start Date :

Jun 1, 2001

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Clinical response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Fallon Clinic at Worcester Medical Center	Worcester	Massachusetts	United States	01608
2	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts	United States	01655