Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | April 5, 2005 | ||||||||
Last Updated Date | November 20, 2010 | ||||||||
Start Date ICMJE | October 2005 | ||||||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Time to treatment failure (e.g., tumor progression, tumor recurrence, or death from any cause) [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE |
Time to treatment failure (e.g., tumor progression, tumor recurrence, or death from any cause) | ||||||||
Change History | Complete list of historical versions of study NCT00107471 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Time to death [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures ICMJE |
Time to death | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma | ||||||||
Official Title ICMJE | A Phase I/II Study of Topotecan With G-CSF and Radiation Therapy in Children With Malignant Intrinsic Pontine Brainstem Gliomas of Childhood | ||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Topotecan may make tumor cells more sensitive to radiation therapy . Giving topotecan and G-CSF together with radiation therapy may be an effective treatment for brain stem glioma. PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when given together with G-CSF and radiation therapy and to see how well they work in treating young patients with newly diagnosed brain stem glioma. |
||||||||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of topotecan followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 out of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed within 2 weeks, every 3 months for 1.5 years, every 6 months for 1.5 years, and then annually until disease relapse. PROJECTED ACCRUAL: A total of 3-72 patients (3-12 for phase I and 60 for phase II) will be accrued for this study within approximately 3 years. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 Phase 2 |
||||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||||
Condition ICMJE | Brain and Central Nervous System Tumors | ||||||||
Intervention ICMJE |
|
||||||||
Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Estimated Enrollment ICMJE | 72 | ||||||||
Completion Date | |||||||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
|
||||||||
Gender | Both | ||||||||
Ages | 3 Years to 21 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States, Australia, Canada, Switzerland | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00107471 | ||||||||
Other Study ID Numbers ICMJE | CDR0000417842, COG-ACNS0224 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | Gregory H. Reaman, Children's Oncology Group - Group Chair Office | ||||||||
Study Sponsor ICMJE | Children's Oncology Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | November 2010 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |