Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts

Neoplasm Clinical Trial

Official title:

Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026858
• Other study ID #: 950003
• Secondary ID: 95-C-0003
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2001
• Last updated: March 3, 2008
• Start date: October 1994
• Est. completion date: November 2002

Study information

• Verified date: November 2002
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome.

Technically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation.

Description:

Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome.

Technically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

INCLUSION CRITERIA:

Patients must sign informed consent.

Supporting institution physicians must agree that therapy is appropriate and safe.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm

Intervention

Behavioral:
• collaboration

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Champlin RE, Goldman JM, Gale RP. Bone marrow transplantation in chronic myelogenous leukemia. Semin Hematol. 1988 Jan;25(1):74-80. Review. — View Citation

Tarbell NJ, Amato DA, Down JD, Mauch P, Hellman S. Fractionation and dose rate effects in mice: a model for bone marrow transplantation in man. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):1065-9. — View Citation

Thomas E, Storb R, Clift RA, Fefer A, Johnson FL, Neiman PE, Lerner KG, Glucksberg H, Buckner CD. Bone-marrow transplantation (first of two parts). N Engl J Med. 1975 Apr 17;292(16):832-43. Review. — View Citation