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


Study Number:
RTOG 0929

Recurrent Glioblastoma

Principal Investigator:

Addtional Investigators:
Rekha Chaudhary


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


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.

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.

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

This entry was posted in . Bookmark the permalink. Both comments and trackbacks are currently closed.
  • Print This Page
  • Make an Appointment: Schedule Now
  • UCNI Weekly Blog
  • Hope Stories

    • Jim’s Story: Pituitary Tumor

      Jim's Story: Pituitary Tumor One turn of events led to another, and so it was that Jim, and not his wife, took Jim’s 87-year-old father to his appointment with the dermatologist for the first time. And so it was that the dermatologist was not...
    • John’s Story: Glioblastoma

      John's Story: Glioblastoma John, a retired painter and carpenter, is a tall, solidly built man with a strong inclination toward getting things done. A former Vista volunteer who was equally comfortable running a food co-op in an underserved neighborhood or standing near the...
    • Brian’s Story: Meningioma

      Brian's Story: Meningioma “Carefree” is the word Brian uses to describe his life back then. He was 39 years old, happily married and the father of three children under the age of 5. “Life was busy, but that felt normal,” he says, reflecting. “The only...
    • Kevin’s Story: Acoustic Neuroma

      Kevin's Story: Acoustic Neuroma Kevin was in his mid-40s when he began to notice that he wasn’t hearing quite as well as in the past. But the change was gradual, so he didn’t worry about it. A few years went by, and the hearing...
    • Blake’s Story: Medulloblastoma

      Blake's Story: Medulloblastoma Blake knew he was in the right hands the moment he saw the surgeon’s wrists. Dr. John M. Tew, Blake’s neurosurgeon, was wearing one of Lance Armstrong’s yellow LiveStrong cancer bracelets. So was Blake. Dr. Tew, who was also sporting...
    • Sandra’s Story Glioma

      Sandra's Story Glioma Sandra (Sandy) is a smiling, breathing reminder that hope exists for patients with even the most challenging type of brain tumors. Nine years ago, when Sandy was first told that she had six months to live, she stared back blankly...
    • Jerry’s Story: Spinal Tumor

      Jerry's Story: Spinal Tumor On an ordinary day in February 2009, John M. Tew, MD, got one of the true surprises of his career. He was seeing patients in his Mayfield Clinic office on the University of Cincinnati medical campus when an unexpected guest...
    • Joe’s Story: Oligodendroglioma

      Joe's Story: Oligodendroglioma Joe calls it a miracle and a gift from “a higher power.” Others might call it a fortuitous turn of fate. Either way, Joe’s experience embodies a reversal of fortune that is both wonderful and startling. Once a man with...
    • Doc’s Story: Metastatic Brain Tumors

      Doc’s Story: Metastatic Brain Tumors First there were headaches. Bad ones. Migraines, probably. Then, one day in mid-May, 2010, his knee, foot and arm went numb on his left side. Darrell “Doc” Rodgers, the 700WLW radio personality, feared he was having a stroke. In the emergency...
    • Bob’s Story: Glioblastoma

      Bob's Story: Glioblastoma Bob’s story blends coincidence with collaboration and hope. The coincidence involves the 62-year-old West Chester man’s best buddy, “Jake,” a 165-pound...
    • Dr. Mike’s Story: Glioblastoma

      Dr. Mike's Story: Glioblastoma Nearly two years after receiving a diagnosis of brain cancer, Dr. Michael Wood continues to attack his disease with wellness. In addition to surgery, radiation, chemotherapy and strong family support, the Cincinnati otolaryngologist has worked hard to provide his own...
    • Lynne’s Story: Brain Metastasis

      Lynne's Story: Brain Metastasis Semiretired and working part-time at a restaurant, Lynne knew something was amiss when she looked at the cash register and then struggled to make her hands produce the correct amount of change. Could she have suffered a stroke? Lynne pushed the...