Thalidomide in Treating Patients With Myelofibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Brief Summary

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Phase II trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.

Detailed Description

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PRIMARY OBJECTIVES:

I. To investigate whether thalidomide, a potent inhibitor of angiogenic and fibrogenic growth factors, is an effective therapeutic agent in patients with MMM. Specifically, to assess whether thalidomide improves anemia and/or organomegaly in patients with MMM.

II. To assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis, collagen and reticulin deposition, and the expression of the mediating growth factors bFGF, TGF-b, and PDGF, and their respective receptors.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 1 additional year of therapy.

Patients are followed every 6 months until 5 years from study entry.

Conditions

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Primary Myelofibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (thalidomide)

Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 1 additional year of therapy.

Group Type EXPERIMENTAL

thalidomide

Intervention Type DRUG

Given PO

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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thalidomide

Given PO

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed myelofibrosis with myeloid metaplasia

* Agnogenic myeloid metaplasia
* Post-polycythemic myeloid metaplasia
* Post-thrombocythemic myeloid metaplasia
* No metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7), or acute myelofibrosis
* No chromosomal translocation t(9;22) or bcr/abl gene rearrangement
* Presence of reticulin fibrosis in bone marrow and leukoerythroblastosis and dacrocytosis in peripheral blood
* Presence of anemia (hemoglobin less than 10 g/dL), palpable splenomegaly, or hepatomegaly
* Performance status - ECOG 0-2
* Absolute neutrophil count greater than 750/mm\^3
* Platelet count less than 400,000/mm\^3
* WBC less than 50,000/mm\^3
* Bilirubin no greater than 2 mg/dL (if total bilirubin elevated, direct bilirubin must be normal)
* AST no greater than 3 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 3 times ULN
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile women must use at least 1 highly active method AND 1 additional effective method of contraception for at least 4 weeks before study, during study, and for at least 4 weeks after study
* Fertile men must use effective contraception during study and for at least 4 weeks after study
* No uncontrolled infection
* No concurrent condition that would preclude study
* No peripheral neuropathy
* At least 1 month since prior interferon, pirfenidone, anagrelide, or epoetin alfa
* At least 1 month since prior hydroxyurea or other chemotherapy
* At least 1 month since prior corticosteroids or androgen derivatives

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Elliott

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

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North Central Cancer Treatment Group

Rochester, Minnesota, United States

Site Status

Countries

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United States