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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02039778
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Beth Israel Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ilan Shapira, MDRahul Parikh, MD
Principal Investigator Affiliation St. Luke's - Roosevelt Hospitals& Beth Israel Medical CenterRoosevelt Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Malignant Glioma, Brain Tumors, Anaplastic Astrocytoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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).

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Roosevelt Hospital, New York, New York

Status

Address

Roosevelt Hospital

New York, New York, 10019

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