Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma (STRONG)

April 28, 2017 updated by: Beth Israel Medical Center

STRONG Trial - Stem Cell Radiotherapy (ScRT) and Temozolomide for Newly Diagnosed High-grade Glioma (HGG): A Prospective, Phase I/II Trial

There are preliminary studies that suggest that radiation therapy to areas of the brain containing cancer stem cells (in addition to the area where the tumor was surgically treated) may help patients with high-grade brain tumors live longer. The purpose of this study is to determine whether the addition of stem-cell radiation therapy to the standard chemoradiation will further improve the outcome. The investigators will collect information about the patient's clinical status, disease control, neurocognitive effects, and quality of life during follow-up in our department.

The purpose of the study is to improve the overall survival patients with newly diagnosed malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The investigators will also measure how patients treated with this novel method of radiation therapy do over time in terms of disease control, potential neurocognitive side effects, overall function, and quality of life.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Even after optimal standard treatment, the outcome for patients suffering from glioblastoma (GB) is currently dismal, and temozolomide adds a modest survival benefit at high monetary cost and is accompanied by considerable toxicity. A possible explanation for the failure of radiotherapy to cure GB is the observation that glioma cells migrate widely into healthy bilateral brain tissue from one or more foci of origin. These isolated cells are not detected by current radiological techniques or even imaging and therefore usually not included into the target volume during radiotherapy. In this present study the investigators would like to test the hypothesis that the dose prescribed to the normal tissue stem cell niche in the adult brain will influence the effectiveness of radiotherapy for patients suffering from HGG/GB as these niches may serve as a harbor for radioresistant glioma stem cells, which are the only cells in a HGG believed to able to repopulate a tumor.

The hypothesis is based on previous reports showing that adult normal tissue stem cells reside in the lateral periventricular regions of the lateral ventricles and animal studies reporting that transformation of normal tissues stem cells but not differentiated cells lead to tumor formation. This unique anatomical pattern of the brain that clearly separates stem cell niches as a potential pool of cancer stem cell (CSC's) from differentiated tissue make this an ideal model system to study the impact of radiation dose given to these stem cell niches. Therefore, prospective, randomized clinical trials are needed to address the efficacy and toxicity of including the CSC-containing subventricular region as additional target volumes into treatment plans for patients suffering from HGG/GB. This intervention could dramatically improve the outcomes of patients suffering from progressive, relapsing disease despite our best efforts currently.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Roosevelt hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with newly diagnosed with high grade glioma (grade 3 or 4) having completed surgery.
  • Patients must be ≥ 18 and ≤ 70 years of age;
  • WHO/ECOG Performance Status of 2 or less.
  • MRI of the brain as delineated above.
  • Patients must sign a study-specific informed consent prior to study entry.

Exclusion Criteria:

  • Evidence of brainstem involvement on radiographs;
  • Evidence of oligodendroglioma histology.
  • Evidence of progressive disease at the time of study entry;
  • Evidence of extracranial distant metastatic disease;
  • Prior cranial irradiation;
  • Patients may not be entered on other studies that have progression free, disease free, or overall survival as a primary endpoint;
  • Patients with synchronous or prior malignancy, other than non-melanomatous skin cancer unless disease free greater than 3 years;
  • Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stem Cell Radiotherapy and Temozolomide

One treatment of 2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy over 6 weeks.

Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.

Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays).
Radiation: Stem Cell Radiotherapy (ScRT) and Temozolomide

Stem Cell Radiotherapy (ScRT) and Temozolomide:

The postoperative surgical bed + edema + margin & the ipsilateral subventricular zone (contoured as a 5mm rim of tissue around the ipsilateral lateral ventricles) will be included within the initial target volume and treated to 46 Gy in 23 fractions. After 46 Gy, the conedown or boost volume (surgical cavity + margin) will be treated to a total of 60 Gy, with seven additional fractions of 2 Gy each (14Gy boost dose).

Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays).

Other Names:
  • Temozolomide
  • Intensity Modulated Radiation Therapy (IMRT)
  • Stem Cell Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 12 months
The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).
12 months
Progression-free Survival
Time Frame: 12 months
The progression-free survival of patients with newly diagnosed HGG treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 36 months
The short-and long-term toxicity of ScRT (and compare to historical controls).
36 months
Neurocognition
Time Frame: 36 month
The potential neurocognitive effects of ScRT by the Hopkins Verbal Learning Test (HVLT), Mini-mental status exam (MMSE), Trail Making Tests A/B (TMT), and Controlled Word Association Test (COWAT).
36 month
Quality of Life
Time Frame: 36 months
The impact of ScRT on health-related quality of life (HRQOL) as assessed by EORTC Quality of Life Questionnaire (EORTC QLQ-C30)/Brain Cancer Module (BCM 20), Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and Activities of Daily Living Scale (ADLS) during ScRT.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Medical Center

Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

  • Principal Investigator: Ilan Shapira, MD, St. Luke's - Roosevelt Hospitals& Beth Israel Medical Center
  • Principal Investigator: Rahul Parikh, MD, Roosevelt hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0151 (OTHER: 13-0151)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma

Clinical Trials on Stem Cell Radiotherapy (ScRT) and Temozolomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe