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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

NCT01012609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-03-14

Study results available
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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.

Conditions

Interventions

OTHER

cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan

External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Phoenix Children's Hospital

    collaborator OTHER

  • Alberta Children's Hospital

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Ira Dunkel, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-30
Primary Completion
2018-01-15
Completion
2018-01-15

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012609 on ClinicalTrials.gov