Status:
COMPLETED
Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Tumor
Central Nervous System Tumor
Eligibility:
All Genders
Up to 10 years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one dr...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptom...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following:
- WHO grade I or II astrocytoma
- Grade I or II oligodendrogliomas
- Mixed oligodendrogliomas
- Gangliogliomas
- Measurable disease
- Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be removed for anatomical reasons are allowed
- Optic pathway tumors allowed provided there is evidence of progressive disease by MRI and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary dysfunction, or diencephalic syndrome
- Dorsally exophytic brainstem gliomas that were previously resected more than 50% are allowed provided the residual tumor shows progression (with or without symptoms)
- No diffuse brain stem tumors
- No type 1 neurofibromatosis
- PATIENT CHARACTERISTICS:
- Age
- 10 and under
- Performance status
- ECOG 0-2
- Lansky 50-100%
- Life expectancy
- Not specified
- Hematopoietic
- Hemoglobin ≥ 8.0 gm/dL
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT \< 2.5 times ULN
- Renal
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
- Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10)
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent immunomodulating agents
- Chemotherapy
- No other concurrent anticancer chemotherapy
- Endocrine therapy
- Prior corticosteroids allowed
- No concurrent corticosteroids except for the treatment of increased intracranial pressure
- Radiotherapy
- Not specified
- Surgery
- See Disease Characteristics
- Prior surgery allowed
- Other
- No other prior therapy
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00077207
Start Date
July 1 2004
End Date
December 1 2013
Last Update
May 16 2018
Active Locations (1)
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1
Childrens Oncology Group
Philadelphia, Pennsylvania, United States, 19104