Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
2 other identifiers
interventional
9
1 country
1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedStudy Start
First participant enrolled
February 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2014
CompletedResults Posted
Study results publicly available
April 27, 2016
CompletedApril 18, 2018
April 1, 2018
4 years
February 10, 2009
March 24, 2016
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)
This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect.
up to 12-16 months
Secondary Outcomes (3)
Time to Neuroradiological Evidence of Tumor Recurrence or Progression
up to 12-16 months
Survival Time
up to 2 years
Time Spent in a Karnofsky Performance Status of 60-100%
up to 12-16 months
Study Arms (1)
Hypofractionation Radiotherapy+Temozolomide
EXPERIMENTALPatients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
Interventions
Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Patients will undergo HIMRT
Patients undergo HIMRT
Eligibility Criteria
You may qualify if:
- Patients who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not involving the brain stem or optics chiasm, diagnosed following biopsy or tumor removal.
- Age \> 18 years
- Given written consent
- Adequate bone marrow reserve(hemoglobin \> 10 grams, Absolute neutrophil count \> 1500 / mm3, platelets \> 100,000/ mm3)
- Normal renal function(BUN \< 24 mg/dL, Creatinine \< 1.3 mg/dL)
- Normal liver function(Total Bilirubin \< 1.5 mg/dL, SGPT/ALT \< 60 U/L)
You may not qualify if:
- Have a Karnofsky score of \< 60 \[Appendix B\] or age \< 18 years.
- Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma.
- Tumors located in the brainstem or optic chiasm.
- Prior radiation therapy to the brain
- Prior chemotherapy within the past 6 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Ammirati M, Chotai S, Newton H, Lamki T, Wei L, Grecula J. Hypofractionated intensity modulated radiotherapy with temozolomide in newly diagnosed glioblastoma multiforme. J Clin Neurosci. 2014 Apr;21(4):633-7. doi: 10.1016/j.jocn.2013.09.005. Epub 2013 Oct 3.
PMID: 24380758RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mario Ammirati, MD
- Organization
- The Ohio State University Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Ammirati, MD
Ohio State University Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
February 13, 2009
Primary Completion
February 13, 2013
Study Completion
November 25, 2014
Last Updated
April 18, 2018
Results First Posted
April 27, 2016
Record last verified: 2018-04