Phase 2 N=118 Treatment

Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

Anaplastic Astrocytoma · Central Nervous System Neoplasm · Glioblastoma · Gliosarcoma · Spinal Cord Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT00100802 ↗

Enrolled (actual)

118

Serious AEs

2.8%

Results posted

Jan 2017

Primary outcome: Primary: One Year Overall Survival — 0.7208 Estimated probability

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Laboratory Biomarker Analysis (Other); Lomustine (Drug); Radiation Therapy (Radiation); Temozolomide (Drug)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY One Year Overall Survival	0.7208	—
PRIMARY Occurrence of Death Attributable to Complications of Protocol Therapy	1	—

Summary

This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.

Eligibility Criteria

Inclusion Criteria

Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following histologies:
Anaplastic astrocytoma
Glioblastoma multiforme
Gliosarcoma
Primary spinal cord malignant gliomas allowed
No primary brainstem tumors
Has undergone surgical resection or biopsy of the tumor within the past 31 days
Pre-operative and post-operative brain MRI with and without gadolinium-contrast OR pre-operative and post-operative spine MRI for spinal cord primaries
Post-operative MRI not required for patients who undergo biopsy only
No evidence of neuraxis dissemination
Spine MRI and cerebrospinal fluid cytology required only if clinically indicated
Performance status - Karnofsky 50-100% (for patients > 16 years of age)
Performance status - Lansky 50-100% (for patients ≤ 16 years of age)
At least 8 weeks
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3 (transfusion independent)
Hemoglobin ≥ 8 g/dL (transfusions allowed)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT ≤ 2.5 times ULN
Albumin ≥ 2 g/dL
Creatinine ≤ 1.5 times ULN
Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal
No evidence of dyspnea at rest
No exercise intolerance
Pulse oximetry ≥ 94% (if determination is clinically indicated)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study participation
Able to swallow oral medication
Seizures allowed provided they are well controlled with anticonvulsants
No hypersensitivity to temozolomide
No prior biologic agents
No prior chemotherapy
Prior corticosteroids allowed
No concurrent corticosteroids as an antiemetic
Concurrent corticosteroids allowed only for treatment of increased intracranial pressure
No concurrent radiotherapy using cobalt-60
See Disease Characteristics
No other prior treatment
No concurrent phenobarbital or cimetidine
No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during study chemoradiotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00100802). 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.