DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Cancer

Intervention: cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan (Other)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Ira Dunkel, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

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 Astrocytomas (POE08-01)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To determine the proportion of patients with high-grade astrocytoma and diffuse pontine tumors achieving one year progression free survival.

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.

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.

To explore whether there are any potential associations between primary tumor tissue molecular markers and tumor response.

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)

To explore whether there are any potential associations between histology (grade) with protein and ELISA measurements of those proteins.

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.

Eligibility

Minimum age: 3 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have either (1) histologic proof of a high-grade astrocytoma reviewed

by a POETIC institutional pathologist or (2) a radiological diagnosis via MRI scan of a typical diffuse pontine tumor made by a POETIC institutional neuroradiologist. Patients with a radiological diagnosis via MRI scan of a typical diffuse pontine tumor will be enrolled on the diffuse pontine tumor arm of the study regardless of histology in cases that are biopsied. Note: For collaborating non-POETIC institutions, the reviews may be done by an institutional pathologist/neuroradiologist.

- Patients must begin study prescribed therapy within 42 days of neurosurgical

resection or biopsy of the tumor (high-grade astrocytoma patients) or radiological diagnosis (diffuse pontine tumor patients).

- Age ≥ 3-years and < 22-years-old.

- Brain MRI (and any other studies done according to clinical indications) must not

show any definitive evidence of leptomeningeal or extra-neural metastases.

- ANC ≥ 1000/μL and platelet count ≥ 100,000/μL

- Patients must have adequate organ function as defined by:

- Hepatic: total bilirubin < 1. 5 mg/dl, AST ≤ 2. 5 x the upper limit of normal.

- Renal: serum creatinine ≤ 1. 5 x the upper limit of normal for age, or calculated

creatinine clearance or nuclear GFR ≥ 70 ml/min/1. 73 m2.

- The patient, or for minors, a parent or legal guardian, must give informed written

consent indicating they are aware of the investigational nature of this study. Exclusion Criteria:

- Evidence of leptomeningeal or extra-neural metastatic disease.

- Prior radiation therapy or chemotherapy

- Pregnancy, mothers unwilling to refrain from breast-feeding, and sexually mature

patients unwilling to practice an effective form of birth control.

- Other significant concomitant medical illnesses that would compromise the patient's

ability to receive all prescribed study therapy.

- Prior therapy which specifically and directly targets the EGFR pathway.

- Prior severe infusion reaction to a monoclonal antibody.

- Significant history of uncontrolled cardiac disease; i. e., uncontrolled hypertension,

unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.

- Patients with known Gilbert's Syndrome.

Locations and Contacts

Alberta Children'S Hospital, Calgary, Alberta T2N 1N4, Canada

Phoenix Children'S Hospital, Phoenix, Arizona 85016, United States

University of Colorado Health Sciences Center, Denver, Colorado, United States

University of Florida, Gainesville, Florida, United States

MD Anderson Cancer Center Orlando at Arnold Palmer Hospital for Children, Orlando, Florida 32806, United States

Children's Healthcare of Atlanta at Egleston, Atlanta, Georgia 30322, United States

John Hopkins Medical Center, Baltimore, Maryland 21287, United States

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Children's Mercy Hospital & Clinics, Kansas City, Missouri 64108, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States

Md Anderson Cancer Center, Houston, Texas 77030, United States

Seattle Children'S Hospital, Seattle, Washington, United States

Additional Information

Memorial Sloan-Kettering Cancer Center

Starting date: November 2009
Last updated: September 30, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017