Adult Glioblastoma Clinical Trial
Official title:
Phase I/Comparative Randomized Phase II Trial of TRC105 Plus Bevacizumab Versus Bevacizumab in Bevacizumab-Naive Patients With Recurrent Glioblastoma Multiforme
This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.
PRIMARY OBJECTIVES:
I. To establish a maximum tolerated dose (MTD) of TRC105 (anti-endoglin monoclonal antibody
TRC105) combined with bevacizumab in this patient population. (Phase I) II. To assess the
safety and adverse events of TRC105 in combination with bevacizumab in this patient
population. (Phase II) III. To determine the efficacy of TRC105 in combination with
bevacizumab in recurrent glioblastoma as measured by progression-free survival and compare it
with the efficacy of bevacizumab alone in this patient population. (Phase II)
SECONDARY OBJECTIVES:
I. To assess the proportion of patients, who are progression free at 6 months, treated with
TRC105 in combination with bevacizumab as compared to bevacizumab alone. (Phase II) II. To
assess the overall survival of patients treated with TRC105 in combination with bevacizumab
compared to bevacizumab alone. (Phase II) III. To compare the impact of the treatment on the
patients quality of life (QOL) using the European Organization for Research and Treatment of
Cancer (EORTC) Quality of Life questionnaire (QLQ)-C15-Palliative Care (PAL) and QLQ-brain
neoplasm (BN)20 Patient Questionnaires. (Phase II) IV. To estimate patient recommendations
for study participation to others using the Was It Worth It (WIWI) Questionnaire. (Phase II)
TERTIARY OBJECTIVES:
I. To evaluate the pharmacokinetics of TRC105. (Phase I) II. To evaluate the immunogenicity
of TRC105. (Phase I) III. To determine the relationship between tumor biomarkers, circulating
biomarkers of vascular response and vascular endothelial growth factor (VEGF)/VEGF receptor
(VEGFR) single-nucleotide polymorphisms (SNPs) in predicting efficacy and/or toxicity of
treatment. (Phase II) IV. To assess the utility of magnetic resonance imaging (MRI) imaging
including apparent diffusion coefficient (ADC) as a predictor of response and survival.
(Phase II) V. To assess the utility of dynamic contrast enhanced (DCE) MRI as a predictor of
response to bevacizumab with or without TRC105. (Phase II)
OUTLINE: This is a phase I dose-escalation study of anti-endoglin monoclonal antibody TRC105,
followed by a randomized phase II study.
Phase I (closed to accrual 1/14/14): Patients receive bevacizumab intravenously (IV) over
30-90 minutes on day 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days
8 and 11 of course 1 and days 1 and 8 of all subsequent courses. Courses repeat every 14 days
in the absence of disease progression or unacceptable toxicity.
Phase II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive bevacizumab IV over 30-90 minutes on day 1 and anti-endoglin
monoclonal antibody TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of
all subsequent courses. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
ARM II: Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years.
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