Clinical Trial: Carboplatin and Bevacizumab for Recurrent Ependymoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Trial of Carboplatin and Bevacizumab for the Treatment of Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma in Adults: A Multi-Center Trial

Brief Summary: The goal of this clinical research study is to learn if the combination of bevacizumab and carboplatin can help to control recurrent pendymoma. The safety of this drug combination will also be studied....

Detailed Summary:

Background:

Ependymomas are glial based tumors arising from the ependymal lining of the ventricular system and central canal of the spinal cord These tumors affect both adults and children and represent approximately 1.2%-7.8% of all intracranial cancers. Currently, the standard therapy for newly diagnosed low-grade ependymoma includes total surgical excision, when possible, followed by radiation therapy. Complete surgical resection is often not possible because of the location of the tumor and the concern for damage to surrounding eloquent brain during surgery. The situation is even more critical for patients with anaplastic ependymomas because of the higher proliferative rate and greater propensity for tumor infiltration into surrounding normal brain, preventing any possibility of complete tumor removal by surgery.

For patients with the more aggressive anaplastic ependymoma, chemotherapy is often administered either before or after the radiation in the hope that infiltrating tumor cells will be eliminated. Extensive experience has been gathered with the use of bevacizumab in other neuroepithelial tumors such as malignant gliomas. Based on the interesting results observed in the reported small series of patients with recurrent ependymomas treated with bevacizumab, as well as on the evidence of VEGF-promoted angiogenesis in these tumors, we designed a phase II study to test the efficacy of bevacizumab in patients with recurrent ependymoma. As results in most types of tumors have indicated that anti-angiogenesis therapies are more effective when given in combination with cytotoxic chemotherapy, in this study bevacizumab will be combined with carboplatin. The choice of carboplatin is justified by the fact that, as detailed above, this remains the most effective agent in this disease, and extensive toxicity data is available
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: progression-free survival (PFS) at one year [ Time Frame: one year after end of treatment ]

Original Primary Outcome: Number of Participants with Progression-Free Survival at 1 Year [ Time Frame: 1 year following treatment ]

Progression-Free Survival (PFS) defined as length of time during and after treatment in which a patient is living with a disease that does not get worse.


Current Secondary Outcome:

  • To evaluate response rates to this chemotherapy. [ Time Frame: end of treatment ]
  • To evaluate overall survival in this population. [ Time Frame: time of death ]
  • To evaluate toxicity profile of this combination. [ Time Frame: completion of study ]
  • To evaluate the occurrence of symptoms and correlate to disease progression and tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT or MDASI-SP) selfreporting tool. [ Time Frame: completion of study ]


Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: February 11, 2011
Date Started: October 19, 2015
Date Completion: July 1, 2020
Last Updated: May 12, 2017
Last Verified: December 1, 2016