Clinical trial NCT01120639: Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
Official title: A Phase 1-2 Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Cancer of Brain and Nervous System
Glioblastoma Multiforme
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose-escalation with 2-level stratification
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

Detailed description: Primary Objective: To determine the maximum tolerated dose (MTD), based on acute CNS toxicity at 30 days, of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme.

Secondary Objectives:

1. Assess the short- and long-term adverse effects.
2. Determine the radiographic response rate.
3. Determine the overall survival rate.
4. Assess quality of life during treatment

To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.

Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
* The tumor must be supratentorial in location
* The planning target volume (tumor plus margin) must measure ≤ 150 cm\^3 in volume
* Age ≥ 18 years
* Life expectancy of at least 12 weeks
* Patient must have adequate organ function to tolerate temozolomide (details in the protocol)

Exclusion Criteria:

* Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
* Tumor foci detected below the tentorium
* Multifocal disease or leptomeningeal spread
* Prior allergic reaction to the study drugs involved in this protocol
* Patients with pacemaker will be allowed to undergo CT instead of MRI
* Pediatric patients (age \< 18), pregnant women, and nursing patients will be excluded

Primary outcomes:
measure: Number of Dose-limiting Toxicities (DLTs)
timeFrame: 30 days
Secondary outcomes:
measure: Number of Acute Toxicity Within 30 Days
timeFrame: 30 days
measure: Long-term Toxicity After More Than 30 Days
timeFrame: 12 months
measure: Percent of Participants With Radiographic Response
timeFrame: 6 months
measure: Progression-free Survival
timeFrame: 18 Months.
measure: Overall Survival (OS)
timeFrame: 20 Months.
measure: Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey
timeFrame: 12 Months
measure: Quality of Life by Brain-20 Survey
timeFrame: 12 months
measure: Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey
timeFrame: 12 months
measure: Treatment Failure Analysis
timeFrame: 18 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Scott Gerard Soltys, MD
role: PRINCIPAL_INVESTIGATOR
References: