Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts

NCT00026858 | Completed Phase 2

• 2 other identifiers: 95000395-C-0003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasm

Keywords

Bone Marrow Transplantation; Leukemia; Breast Cancer; Multiple Myeloma; Total Body Irradiation

Interventions

collaboration BEHAVIORAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must sign informed consent.
• Supporting institution physicians must agree that therapy is appropriate and safe.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1016/0360-3016(87)90046-0.

  PMID: 3298176 BACKGROUND

• 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. doi: 10.1056/NEJM197504172921605. No abstract available.

  PMID: 234595 BACKGROUND

• Champlin RE, Goldman JM, Gale RP. Bone marrow transplantation in chronic myelogenous leukemia. Semin Hematol. 1988 Jan;25(1):74-80. No abstract available.

  PMID: 3279516 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Leukemia; Breast Neoplasms; Multiple Myeloma

Interventions

Intersectoral Collaboration

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 14, 2001
• First Posted: November 15, 2001
• Study Start: October 1, 1994
• Study Completion: November 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-11

Locations

US (1)