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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00015990
Other study ID # NCI-2012-01856
Secondary ID N998BU10CA025224
Status Completed
Phase Phase 2
First received May 6, 2001
Last updated January 23, 2013
Start date April 2001

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


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)


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
thalidomide
Given orally
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States North Central Cancer Treatment Group Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Up to 3 months No
Primary Incidence and severity of toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Up to 5 years Yes
Secondary Survival time Estimated using the method of Kaplan-Meier. Time from registration to death due to any cause, assessed up to 5 years No
Secondary Time to disease progression Estimated using the method of Kaplan-Meier. Time from registration to documentation of disease progression, assessed up to 5 years No
Secondary Duration of response measured using criteria reported by Cheson et al Date at which the patient's objective status is first noted to be either a CHR or PR to the date progression is documented, assessed up to 5 years No
Secondary Time to treatment failure Time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years No
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