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| ID | Type | Description | Link |
|---|---|---|---|
| COG-ADVL0012 | Other Identifier | Children's Oncology Group | |
| CCG-ADVL0012 | Other Identifier | Children's Cancer Group | |
| ALK-01-042 | |||
| CCG-09802 | Other Identifier | Children's Cancer Group | |
| CDR0000067715 | Other Identifier | ClinicalTrials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
OBJECTIVES:
OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy.
The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients.
Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days | Experimental |
| |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days | Experimental |
| |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days | Experimental |
| |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years |
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DISEASE CHARACTERISTICS:
Newly diagnosed diffuse, intrinsic brain stem gliomas
Measurable disease
No disseminated disease at sites other than brain stem
No neurofibromatosis
Treatment must begin within 31 days of diagnosis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 24 hours since any of the following medications:
No other prior therapy for brain stem glioma
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| Name | Affiliation | Role |
|---|---|---|
| Roger J. Packer, MD | Children's National Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| Lucile Packard Children's Hospital at Stanford |
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|
| cereport | Drug |
|
|
| radiation therapy | Radiation |
|
| Palo Alto |
| California |
| 94304 |
| United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94143-0128 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Albert Einstein Clinical Cancer Center | The Bronx | New York | 10461 | United States |
| Children's Hospital Medical Center - Cincinnati | Cincinnati | Ohio | 45229-3039 | United States |
| Doernbecher Children's Hospital | Portland | Oregon | 97201-3098 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C089876 | RMP 7 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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