Glioblastoma Multiforme/Anaplastic Astrocytoma Clinical Trial
Official title:
A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
| Verified date | April 2018 |
| Source | Ohio State University Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | November 25, 2014 |
| Est. primary completion date | February 13, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University Comprehensive Cancer Center |
United States,
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 Oc — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Time to Neuroradiological Evidence of Tumor Recurrence or Progression | As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect. | up to 12-16 months | |
| Secondary | Survival Time | All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient's physician deems it in the patient's interest not to continue or upon patient request. | up to 2 years | |
| Secondary | Time Spent in a Karnofsky Performance Status of 60-100% | Time spent in a KPS =70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS<70) or censored at the last date the patient was known with KPS =70. The KPS higher scores indicates normal activity status. | up to 12-16 months |