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Low Dose Radiation Therapy for Glioblastoma Multiforme

Study Purpose

To evaluate the safety and effectiveness of low dose rate radiation therapy plus temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have recurrent GBM (Glioblastoma Multiforme)or Anaplastic Astrocytoma.
  • - The diagnosis of GBM or Anaplastic Astrocytoma.
  • - Patients must have been previously treated with surgical resection (any extent okay) and adjuvant radiation therapy plus temozolomide.
  • - Patients must be at least 12 months from completion of radiation therapy.
  • - At least 2 months from completion of temozolomide (to be consistent with the the "rechallenge" group from Perry et al.
JCO 2010).
  • - Age >18 years.
  • - ECOG performance status <2 (Karnofsky >60%, see appendix A).
  • - There must be measurable disease on MRI.
  • - Patients must have normal organ and marrow function as defined below: - Women must not be pregnant.
  • - Ability to understand and the willingness to sign a written informed consent document.
  • - Temozolomide re-treatment is planned by the treating neuro-oncologist.
  • - The most recent brain tumor pathology obtained for the patient must be glioblastoma.

Exclusion Criteria:

  • - Must be able to receive an MRI.
  • - Patients may not be receiving any other investigational cancer treatment agents at the time of enrollment.
  • - Patients may not have previously failed treatment with salvage temozolomide.
  • - Patients may not have previously failed treatment with a VEGF inhibitor.
  • - Patients may not have previously been treated with >1 course of radiotherapy.
  • - Patients may not have previously been treated with radiosurgery to the brain.
  • - Uncontrolled intercurrent illness.
  • - Pregnant and breastfeeding women are excluded.
Women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.

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.

 NCT01466686
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.

 Phase 2
Lead Sponsor

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

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

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

 Kristin Redmond, M.D.
Principal Investigator Affiliation Johns Hopkins University
Agency Class

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

 Other
Overall Status Completed
Countries United States
Conditions

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

 High Grade Glioma
Additional Details

In vitro and in vivo studies have suggested that low dose fractionated radiation therapy (LDFRT) may be used to potentiate full dose chemotherapy, decreasing the development of resistance found with standard doses of radiation and chemotherapy. This is a nonrandomized, open label, single institution phase II trial with a safety run-in to evaluate the safety and efficacy of LDFRT plus temozolomide in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) previously treated with surgical resection followed by adjuvant radiation therapy plus temozolomide. The primary objective of the phase II study is to estimate response rate in patients treated with twice daily fractions of low dose radiation plus temozolomide chemotherapy.

Arms & Interventions

Arms

Experimental: Temozolomide with Low Dose Fractionated Radiation Therapy

All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide.

Interventions

Radiation: - Low Dose Fractionated Radiation Therapy (LDFRT)

All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below.

Drug: - Temozolomide

All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression.

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.

Sibley Memorial Hospital, Washington, District of Columbia

Status

Address

Sibley Memorial Hospital

Washington, District of Columbia, 20016

Baltimore, Maryland

Status

Address

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231

Suburban Hospital, Bethesda, Maryland

Status

Address

Suburban Hospital

Bethesda, Maryland, 20814

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