Clinical Trial: External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Trial of External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocyt
Brief Summary:
Standard treatment for patients with diffuse pontine tumors is radiation therapy, but less than 10% of patients are cured. Adding standard chemotherapy has not improved the cure rate.
Standard treatment for high-grade astrocytomas is surgery and radiation. The surgeon removes as much of the tumor as she or he can. Radiation after that tries to kill any cancer cells that are left. Some patients also get chemotherapy. These are anti-cancer drugs. They can be given during or after radiation. Current standard treatments do not cure many patients.
In this study the doctors are adding a new medication called cetuximab to the treatment and will also use a chemotherapy medication (irinotecan) that has been promising for patients treated for recurrent disease.
Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome:
- To determine the proportion of patients with high-grade astrocytoma and diffuse pontine tumors achieving one year progression free survival. [ Time Frame: 1 year ]
- To determine the safety of cetuximab administered weekly in conjunction with involved field external beam radiation therapy for diffuse pontine tumors and high-grade astrocytomas. [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To estimate the response rate, time to progression, and overall survival in 2 cohorts of patients (diffuse intrinsic pontine tumors, high-grade astrocytomas) treated on this protocol. [ Time Frame: 2 years ]
- To explore whether there are any potential associations between primary tumor tissue molecular markers and tumor response. [ Time Frame: 2 years ]
- Identify CSF protein markers that might indicate the presence of a brain tumor, to validate proteomic methodology by correlating protein & ELISA measurements of known proteins implicated in angiogenesis & tumor progression (VEGF, bFGF, SPARC, attractin) [ Time Frame: 2 years ]
- To explore whether there are any potential associations between histology (grade) with protein and ELISA measurements of those proteins. [ Time Frame: 2 years ]
- To investigate whether the rash associated with cetuximab is secondary to an inflammatory pathway initiated and mediated by the action of cetuximab on host cells. [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: November 11, 2009
Date Started: November 2009
Date Completion: November 2017
Last Updated: October 3, 2016
Last Verified: October 2016
