Phase 2 N=25 Treatment

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

Central Nervous System Tumor, Pediatric

Bottom Line

View on ClinicalTrials.gov: NCT00084838 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Dec 2015

Primary outcome: Primary: 2-yr Overall Survival — 0.70 probability

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: filgrastim (Biological); cisplatin (Drug); cyclophosphamide (Drug); cytarabine (Drug); dexrazoxane hydrochloride (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); leucovorin calcium (Drug); methotrexate (Drug); temozolomide (Drug); therapeutic hydrocortisone (Drug); vincristine sulfate (Drug); radiation therapy (Radiation); Dactinomycin (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: Dana-Farber Cancer Institute
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 2-yr Overall Survival	0.70	—
SECONDARY Pre-Radiation Therapy Chemotherapeutic Response	0.58	—

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.

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

View full record on ClinicalTrials.gov →

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.