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

Roswell Park Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Graft Versus Host Disease; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Treatments: Drug: thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00003894

RPCI-RP-9809

CDR0000067064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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