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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003894
• Other study ID #: CDR0000067064
• Secondary ID: RPCI-RP-9809
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 3, 2011
• Start date: March 1999
• Est. completion date: June 2002

Study information

• Verified date: March 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2002
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• thalidomide

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Cancer Center of the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Louisiana State University School of Medicine	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States,