Clinical Trial ECOG N0577
- Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma
- Principal Investigator
- Priya Kumthekar
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG N0577
- The two main reasons this research study is being done are to see if: •Patients improve if they get treatment with the combination of both radiation therapy and temozolomide chemotherapy as compared to patients who receive treatment with radiation therapy alone. •Patients treated with temozolomide therapy alone (no radiation therapy) have a better or worse quality of life than those patients who are treated with either the combination of radiation therapy and temozolomide or radiation therapy alone.
- This research study is being done in people who have a certain type of brain tumor, called “anaplastic oligodendroglioma.” Temozolomide is approved by the Food and Drug Administration (FDA) to treat aggressive brain tumor, also known as glioblastoma multiforme as well as melanoma, a form of skin cancer. However, temozolomide is considered experimental for anaplastic glioma.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must be newly diagnosed with anaplastic glioima (less than or equal to three months from surgical diagnosis).
- Participants will be excluded if they have received any prior surgery, radiotherapy or chemotherapy for any central nervous system tumor (hormones, vitamins and growth factors are not considered chemotherapy for the purposes of this study).
- Description of Treatment
- Participants in this study will be "randomized" into one of the study groups (radiation therapy alone [Arm A], radiation therapy with temozolomide given during and after radiation therapy [Arm B], and temozolomide alone [Arm C]). Randomization means that participants are put into a group by chance (as in a roll of the dice). Participants in group 1 (Arm A) will get radiation therapy Monday through Friday for about 6-7 weeks. Participants in group 2 (Arm B) will get radiation therapy Monday through Friday as well as daily (7 days a week) temozolomide by mouth for about 6-7 weeks. Participants will then have a 4-week treatment break. After that, participants will get temozolomide alone week 1 (days 1 through 5) every 28 days for up to one year. Participants in group 3 (Arm C) will get temozolomide week 1 (days 1 through 5) every 28 days for up to one year.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Priya Kumthekar
- A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation
- A Phase 1 Open-label, Multicenter Study To Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884), and to Estimate the Maximum Tolerated Dose in Subjects With Advanced or Refractory Cancer
- A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme
- A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined with Bevacizumab vs. Bevacizumab Monotherapy in Patients with Recurrent Glioblastoma
- A Phase II Trial of Bevacizumab in Patients with Recurrent Solid Tumor Brain Metastases Who Have Failed Whole Brain Radiation Therapy
last updated: 27-Jul-16 12:42 AM
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