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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003909 |
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: motexafin gadolinium Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations
Show 31 Study Locations| Study Chair: | Minesh P. Mehta, MD | University of Wisconsin, Madison |
More Information
| ClinicalTrials.gov Identifier: | NCT00003909 History of Changes |
| Other Study ID Numbers: | CDR0000067087, COG-A09712, CCG-09712 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 17, 2010 |
| Health Authority: | United States: Federal Government |
|
untreated childhood brain stem glioma |
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Motexafin gadolinium Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |