NCT00003894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 1999

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

June 17, 2004

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

10 months

First QC Date

November 1, 1999

Last Update Submit

March 3, 2011

Conditions

Graft Versus Host DiseaseUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specificunspecified adult solid tumor, protocol specificgraft versus host disease

Interventions

thalidomideDRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112-2822, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Cancer Center of the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Barbara Jean Bambach, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 17, 2004

Study Start

March 1, 1999

Primary Completion

January 1, 2000

Study Completion

June 1, 2002

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(10)