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Thalidomide in Treating Patients With Myelodysplastic Syndrome

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Refractory Anemia With Ringed Sideroblasts; Secondary Myelodysplastic Syndromes

Intervention: thalidomide (Drug); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Alvaro Moreno Aspitia, Principal Investigator, Affiliation: North Central Cancer Treatment Group

Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have myelodysplastic syndrome. Thalidomide may improve the immune system's ability to fight myelodysplastic syndrome

Clinical Details

Official title: Phase II Study of Thalidomide in the Treatment of Myelodysplastic Syndromes in Adults: A Clinical and Biologic Study

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Confirmed response defined as complete hematologic response (CHR) or partial response (PR) or hematological improvement (HI) on 2 consecutive evaluations in terms of proportion of successes measured using criteria reported by Cheson et al

Incidence and severity of toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

Secondary outcome:

Survival time

Time to disease progression

Duration of response measured using criteria reported by Cheson et al

Time to treatment failure

Detailed description: OBJECTIVES: I. Determine whether thalidomide improves cytopenias in patients with myelodysplastic syndromes. II. Determine the toxicity of this regimen in these patients. III. Determine whether this regimen down regulates the peripheral blood levels of tumor necrosis factor alpha, interferon gamma, and interleukin-12 and whether these changes correlate with clinical response in these patients. IV. Determine whether this regimen alters the peripheral blood T-cell subset distribution and whether these changes correlate with clinical response in these patients. V. Determine the effect of this regimen on bone marrow microvessel density and whether these effects correlate with clinical response in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (favorable vs unfavorable). (Favorable stratum closed to accrual 12/28/01) Patients receive oral thalidomide once daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 1 year and then annually for 4 years. PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study within 20 months. (Favorable stratum closed to accrual 12/28/01)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Pre-transfusion hemoglobin =< 10 g/dL

- Pre-transfusion platelet count =< 50,000/μL

- Absolute neutrophil count < 1000/μL

- Total bilirubin ≤ 1. 5 x UNL

- Alkaline phosphatase ≤ 3 x UNL

- AST ≤ 3 x UNL

- Creatinine ≤ 1. 5 x UNL

- A diagnosis of MDS as demonstrated in the bone marrow; any subtypes are eligible

including:

- Refractory anemia (cytopenia)

- Refractory anemia with ringed sideroblasts

- Chronic myelomonocytic leukemia

- Refractory anemia with excess blasts

- Refractory anemia with excess blasts in transformation

- Unclassified MDS

- Patients with refractory anemia with excess blasts in transformation who are not

candidates for (or who decline) induction chemotherapy are eligible; those patients who were candidates for (and accepted) induction chemotherapy should have failed at least 1 chemotherapy regimen prior to entry

- Patients who are candidates for marrow transplantation should have this option

discussed prior to study entry Exclusion Criteria:

- Any of the following as this regimen may be harmful to a developing fetus or nursing

child:

- Pregnant women

- Nursing women

- Women of childbearing potential or their sexual partners who are unwilling to

employ 2 adequate methods of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)

- Peripheral neuropathy (by history or clinical exam)

- Concomitant therapy ≤ 30 days for myelodysplastic syndrome with any specific agent

including chemotherapy, corticosteroids and/or growth factors (i. e. erythropoietin, G-CSF, GM-CSF, thrombopoietic agent); patients on chronic low-dose corticosteriods (< 20 mg/d) for reasons other than MDS are allowed

- Uncontrolled infections

Locations and Contacts

North Central Cancer Treatment Group, Rochester, Minnesota 55905, United States
Additional Information

Starting date: April 2001
Last updated: January 23, 2013

Page last updated: August 23, 2015

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