Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome - Full Text View

Sponsored by:	Fallon Clinic
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053001

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 Diseases	Biological: epoetin alfa Drug: thalidomide	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
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 Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Thalidomide Erythropoietin Epoetin alfa

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical response

Study Start Date:

June 2001

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..

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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 9, 2009
ClinicalTrials.gov Identifier:	NCT00053001 History of Changes
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
myelodysplastic/myeloproliferative disease, unclassifiable
childhood myelodysplastic syndromes

Study placed in the following topic categories:

Epoetin Alfa
Anti-Infective Agents
Immunologic Factors
Thalidomide
Precancerous Conditions
Hematinics
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myelodysplastic Syndromes
Anemia
Myeloproliferative Disorders
Leukemia, Myeloid

Angiogenesis Inhibitors
Immunosuppressive Agents
Anti-Bacterial Agents
Leukemia
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasm Metastasis
Chronic Myelogenous Leukemia
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Myelodysplastic Myeloproliferative Disease

Additional relevant MeSH terms:

Epoetin Alfa
Anti-Infective Agents
Precancerous Conditions
Thalidomide
Immunologic Factors
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Leukemia
Anti-Bacterial Agents
Preleukemia
Pathologic Processes
Syndrome
Therapeutic Uses
Growth Inhibitors

Angiogenesis Modulating Agents
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Hematinics
Growth Substances
Myelodysplastic Syndromes
Myeloproliferative Disorders
Anemia
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases

ClinicalTrials.gov processed this record on September 11, 2009