Status:
COMPLETED
Low Dose Radiation Therapy for Glioblastoma Multiforme
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
High Grade Glioma
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
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 M...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01466686
Start Date
September 1 2012
End Date
December 1 2022
Last Update
July 3 2023
Active Locations (3)
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1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
2
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
3
Suburban Hospital
Bethesda, Maryland, United States, 20814