Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I/II Trial of Temozolomide and ABT-888 in Subjects With Newly Diagnosed Glioblastoma Multiforme
RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving ABT-888 together with
radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-888 when
given together with radiation therapy and temozolomide and to see how well it works in
treating patients with newly diagnosed glioblastoma multiforme.
OBJECTIVES:
Primary
- To determine the maximum tolerated dose (MTD) of ABT-888 when administered in
combination with radiotherapy and temozolomide in patients with newly diagnosed
glioblastoma multiforme. (Phase I)
- To estimate the overall survival of patients treated with ABT-888 when administered at
the MTD in combination with radiotherapy and temozolomide. (Phase II)
Secondary
- To assess the toxicity associated with this regimen. (Phase I)
- To assess and describe the pharmacokinetics of ABT-888. (Phase I)
- To estimate the frequency of toxicity associated with this regimen. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of ABT-888 followed by a phase
II study.
- Initiation therapy: Patients receive oral ABT-888 twice daily (once on day 1 only) and
oral temozolomide once daily (beginning on day 2) in weeks 1-6. Patients enrolled in the
phase I dose-escalation/phase II portion of the study also undergo concurrent
radiotherapy once daily 5 days a week (beginning on day 2) in weeks 1-6. Treatment
continues in the absence of disease progression or unacceptable toxicity.
- Maintenance therapy: Beginning 4 weeks after completion of initiation therapy, patients
receive oral ABT-888 twice daily on days 1-7 and oral temozolomide once daily on days
1-5. Treatment repeats every 28 days for up to 4 courses (6 courses for patients
enrolled in the phase I dose-escalation/phase II portion of the study) in the absence of
disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic, pharmacogenetic, and
pharmacodynamic analysis. Samples are analyzed for concentration of ABT-888 in plasma by
reversed-phase isocratic high performance liquid chromatography with electrospray ionization
mass spectrometry; identification of novel markers of treatment response by plasma proteomic
evaluation; DNA methylation and/or mutation; and PARP inhibition by ELISA.
After completion of study therapy, patients are followed every 2 months.
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