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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


Phase 2
21 Years
N/A
Not Enrolling
Both
Anemia, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

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


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..

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Clinical response

Principal Investigator

Laszlo Leb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fallon Clinic

Authority:

United States: Federal Government

Study ID:

FALLON-PR01-09-010

NCT ID:

NCT00053001

Start Date:

June 2001

Completion Date:

October 2007

Related Keywords:

  • Anemia
  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • 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
  • Anemia
  • Neoplasms
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Fallon Clinic at Worcester Medical CenterWorcester, Massachusetts  01608