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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00650923 |
RATIONALE: Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor. 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 aflibercept together with radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of aflibercept when given together with radiation therapy and temozolomide in treating patients with newly diagnosed or recurrent glioblastoma multiforme, gliosarcoma, or other malignant glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: aflibercept Drug: temozolomide Genetic: DNA methylation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: pharmacological study Procedure: adjuvant therapy Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Aflibercept (VEGF Trap) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Malignant Glioma |
Estimated Enrollment: | 90 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter, dose-escalation study of aflibercept. Patients are assigned to 1 of 3 treatment groups according to prior treatment and diagnosis.
In all groups, treatment continues in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for analysis of pharmacokinetics by ELISA. Tumor biomarkers and plasma angiogenic peptides are analyzed for correlation with response, and tumor MGMT promoter methylation status is determined using methylation-specific PCR.
After completion of study treatment, patients are followed every 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed intracranial glioblastoma multiforme or gliosarcoma
No evidence of significant intratumoral or peritumoral hemorrhage on pre-operative MRI or a large amount of peri-operative parenchymal hemorrhage on post-operative MRI
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease within the past 6 months, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent full-dose anticoagulants (e.g., warfarin or low molecular-weight heparin)
Study ID Numbers: | CDR0000590174, ABTC-0701, NABTC-0701 |
Study First Received: | April 1, 2008 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00650923 History of Changes |
Health Authority: | Unspecified |
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult anaplastic astrocytoma |
adult anaplastic oligodendroglioma adult mixed glioma recurrent adult brain tumor |
Glioblastoma Astrocytoma Adjuvants, Immunologic Central Nervous System Neoplasms Temozolomide Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Antineoplastic Agents, Alkylating Glioma Glioblastoma Multiforme Gliosarcoma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |