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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thalidomide
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific, graft versus host disease

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arkansas Children's Hospital
  • University of Kansas Medical Center
  • Louisiana State University School of Medicine
  • Roswell Park Cancer Institute
  • Simmons Cancer Center - Dallas
  • Brooke Army Medical Center
  • Cook Children's Medical Center - Fort Worth
  • University of Texas - MD Anderson Cancer Center
  • Cancer Center of the Medical College of Wisconsin
  • Medical College of Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 3, 2011
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00003894
Brief Title
Thalidomide in Treating Patients With Chronic Graft-Versus-Host Disease Following Bone Marrow Transplant
Official Title
Thalidomide vs. Placebo for Steroid Dependent or Refractory Chronic Graft vs. Host Disease (cGVHD) IND #42782
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific, graft versus host disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Jean Bambach, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Louisiana State University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2822
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Center of the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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

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