Thalidomide in Treating Patients With Chronic Graft-Versus-Host Disease Following Bone Marrow Transplant

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00003894

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Thalidomide may interfere with the body's ability to recognize transplanted bone marrow cells as foreign and may help treat patients with graft-versus-host disease.

PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating patients who have chronic graft-versus-host disease following bone marrow transplantation.

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Drug: thalidomide	Phase 2

Detailed Description

OBJECTIVES: I. Determine the efficacy of thalidomide in patients with steroid dependent or refractory chronic graft vs host disease following an allogeneic bone marrow transplant. II. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to the type of bone marrow transplant received (allogeneic vs matched unrelated donor) and type of chronic graft vs host disease (steroid dependent vs steroid refractory). Patients receive either oral thalidomide or placebo 2-4 times a day for 6 months. The drug is then tapered until stopped. If disease recurs, the drug may be restarted for a second 6 month course. The maximum duration of treatment is 18 months. Patients continue on steroid therapy, which is tapered during study therapy. If no response is seen after 8 weeks, patients may cross over to the other alternate drug. Patients are followed weekly for 1 month, then every month for 1 year.

PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Intervention Model:

Parallel Assignment

Primary Purpose:

Supportive Care

Official Title:

Thalidomide vs. Placebo for Steroid Dependent or Refractory Chronic Graft vs. Host Disease (cGVHD) IND #42782

Study Start Date :

Mar 1, 1999

Actual Primary Completion Date :

Jan 1, 2000

Actual Study Completion Date :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed chronic graft vs host disease following an allogeneic bone marrow transplant (BMT) Greater than 100 days since BMT Must be receiving at least 1 mg/kg of prednisone or equivalent immunosuppression

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Not specified Life expectancy:

Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202-3591
2	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
3	Louisiana State University School of Medicine	New Orleans	Louisiana	United States	70112-2822
4	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
5	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
6	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
7	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas	United States	76104
8	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030
9	Cancer Center of the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
10	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226