A Randomized Phase I/II Study of ABT-888 in Combination with Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma

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Study Number:
RTOG 0929

Topic:
Recurrent Glioblastoma

Principal Investigator:
Redmond

Addtional Investigators:
Rekha Chaudhary

Ongoing:
Ongoing

Place:
Barrett Center, Medical Arts Building, University Pointe, Department of Veterans Affairs

Overview:

It appears that your glioblastoma has become resistant to the anticancer effects of temozolomide.  Based on scientific research, it is believed that adding another drug, called ABT-888, to temozolomide may overcome your tumor’s resistance to temozolomide and potentially bring your tumor back under control.   The purpose of this study is to test the safety and efficacy of ABT-888 and temozolomide when combined at different dosing combinations.  We want to find out what effects, good and/or bad, this combination has on you and your brain tumor. The first part of the study (phase I component) will test ABT-888 and temozolomide combined at different dose levels.  When a maximum safe dose level combination is determined, the study (phase II component) will compare that combination to a second, already determined safe dose level combination, given on a different schedule, to see which combination is better at improving the outcome of glioblastoma tumors. Eligible participants will first enter into phase I of this study.  You will receive temozolomide and ABT-888 on days 1-21 of a 28-day schedule.  You can receive the combination indefinitely unless your disease progresses or you develop unwarranted side effects. The ABT-888 will be taken twice a day.  One of the doses will be taken at bedtime with temozolomide.  Both medications are taken orally on an empty stomach. If you are entered into the phase II part of this study, you will be randomized to receive temozolomide and ABT-888 according to one of the study groups described below. If you are in group 1:  You will receive temozolomide and ABT-888 at the maximum safe dose level combination determined from the phase I portion of the study.  You will receive the temozolomide and ABT-888 on days 1-21 of a 28-day schedule, as was given in the phase I portion.  You can receive the combination until your disease becomes worse. If you are in group 2:  You will receive temozolomide and ABT-888 at a dose level combination already determined to be safe in an earlier study.  You will receive the temozolomide and ABT-888 on days 1-5 of a 28-day schedule.  You can receive the combination until your disease becomes worse. While you are receiving the temozolomide and ABT-888, you will visit your study doctor for regular office visits every 28 days for a medical history/physical and performance status.  You will also receive blood tests to monitor how the study drugs are affecting your body; you will receive these tests at weekly to monthly intervals depending on the test results.  In addition, you will receive an MRI every 8 weeks. You will be asked to complete a medication diary while you are receiving treatment; this will help document when you take your medication and any side effects you experience. About 7 to 28 people will be treated in the first part of the study, and 212 people will be treated on the second part of the study.  A total of 240 patients are the most that would be able to enter the study with about 5 participating locally or either part.

Qualifications:
Eligible patients must be at least 18 years old and have a malignant brain tumor called glioblastoma that is growing or progressing despite treatment with radiation therapy and temozolomide.

Contact:
For more information, please contact Alison Kastl, BS, CCRC, Director of Clinical Trials, at kastla@ucmail.uc.edu or (513) 584-0436.

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