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Low Dose Radiation Therapy for Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01466686
Recruitment Status : Recruiting
First Posted : November 8, 2011
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE November 3, 2011
First Posted Date  ICMJE November 8, 2011
Last Update Posted Date December 5, 2019
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
Response Rate [ Time Frame: 3, 6 and 12 month follow-up after therapy has been completed ]
To estimate the response rate to salvage temozolomide plus LDFRT.
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2011)
  • Safety [ Time Frame: 12 months ]
    To select a safe tolerated dose schedule (ie: number of consecutive twice daily fractions) of LDFRT + temozolomide based on hematologic toxicity at one month following initiation of therapy.
  • Tolerability [ Time Frame: 12 months ]
    To select a tolerated dose schedule (ie: number of consecutive twice daily fractions) of LDFRT + temozolomide based on hematologic toxicity at one month following initiation of therapy.
Change History Complete list of historical versions of study NCT01466686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • Time to Progression [ Time Frame: 3, 6 and 12 month follow-up after therapy has been completed ]
    To estimate the 6 month progression free survival in patients treated with LDFRT + temozolomide for recurrent HGG.
  • Overall Survival Rate [ Time Frame: 3, 6 and 12 month follow-up after therapy has been completed ]
    To estimate the overall survival in patients treated with LDFRT plus temozolomide for recurrent HGG.
  • Hematologic Toxicity [ Time Frame: 3, 6 and 12 month follow-up after therapy has been completed ]
    To estimate the hematologic toxicity of salvage LDFRT + temozolomide.
  • Radiation-Associated Long-Term Toxicity [ Time Frame: 3, 6 and 12 month follow-up after therapy has been completed ]
    1M+To estimate the radiation-associated acute and long-term neurologic toxicity of salvage LDFRT + temozolomide.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2011)
Radiation Toxicity [ Time Frame: 12 months ]
To estimate the acute and late radiation-associated neurologic toxicity of salvage LDFRT + temozolomide.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Radiation Therapy for Glioblastoma Multiforme
Official Title  ICMJE A Phase II Trial of Low Dose Fractionated Radiation Therapy as a Chemo-Potentiator of Salvage Temozolomide for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme
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 Multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE High Grade Glioma
Intervention  ICMJE
  • 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. 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.
  • 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.
Study Arms  ICMJE 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)
  • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2011)
49
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristin Redmond, M.D. 410-614-1642 kjanson3@jhmi.edu
Contact: Kristi Purcell, R.N. 410-614-3950 kpurcel2@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01466686
Other Study ID Numbers  ICMJE J11120
NA_00065863 ( Other Identifier: Johns Hopkins University School of Medicine )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristin Redmond, M.D. Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP