Phase 2
Completed N=25
Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT
Central Nervous System Tumor, Pediatric
Source: ClinicalTrials.gov NCT00084838 ↗
Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Dec 2015
Primary outcomePrimary: 2-yr Overall Survival — 0.70 probability
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-yr Overall Survival |
0.70 | — |
| SECONDARY Pre-Radiation Therapy Chemotherapeutic Response |
0.58 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary intracranial Central Nervous System (CNS) atypical teratoid/rhabdoid tumor OR
- Tumor tissue that possesses the INI-1 gene mutation
- No metastases that disseminate outside the CNS by abdominal and chest computer tomography (CT) scans, kidney imaging, and bone marrow biopsy
- No obstruction of cerebrospinal fluid (CSF) flow by CSF flow study
- Definitive surgical resection of tumor within the past 35 days
PATIENT CHARACTERISTICS:
Age
- 18 and under
Performance status
- Karnofsky 50-100% OR
- Lansky 50-100%
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin > 10 g/dL
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- SGPT < 10 times normal
Renal
- Creatinine ≤ 1.5 times normal
Other
- Willing to have placement of central venous access line
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior steroids allowed
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Other
- No other prior or concurrent investigational agents
- Concurrent anticonvulsant agents allowed
Data sourced from ClinicalTrials.gov (NCT00084838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.