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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003909 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: motexafin gadolinium Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of motexafin gadolinium.
Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic brainstem glioma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027-0700 | |
Children's Hospital of Orange County | |
Orange, California, United States, 92868 | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
Stanford Cancer Center at Stanford University Medical Center | |
Palo Alto, California, United States, 94304-1812 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
United States, Georgia | |
MBCCOP-Medical College of Georgia Cancer Center | |
Augusta, Georgia, United States, 30912-4000 | |
United States, Indiana | |
Riley's Children Cancer Center at Riley Hospital for Children | |
Indianapolis, Indiana, United States, 46202-5225 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
University of Minnesota Cancer Center | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
SUNY Upstate Medical University Hospital | |
Syracuse, New York, United States, 13210 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
MBCCOP - South Texas Pediatrics | |
San Antonio, Texas, United States, 78229-3900 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States, 98105 | |
Australia, Western Australia | |
Princess Margaret Hospital for Children | |
Perth, Western Australia, Australia, 6001 | |
Canada, Ontario | |
Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 | |
Canada, Quebec | |
Hopital Sainte Justine | |
Montreal, Quebec, Canada, H3T 1C5 |
Study Chair: | Minesh P. Mehta, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000067087, COG-A09712, CCG-09712 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003909 History of Changes |
Health Authority: | United States: Federal Government |
untreated childhood brain stem glioma |
Neuroectodermal Tumors Photosensitizing Agents Brain Stem Glioma, Childhood Radiation-Sensitizing Agents Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Central Nervous System Neoplasms Motexafin gadolinium Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Motexafin gadolinium Pharmacologic Actions Neuroectodermal Tumors Photosensitizing Agents |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Dermatologic Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |