Tarceva/Rapamycin for Children With Low-grade Gliomas With or Without Neurofibromatosis Type 1 (NF1)

NCT ID: NCT00901849

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-10-31

Brief Summary

This study will evaluate the feasibility of combining two drugs, Tarceva (an anti-EGFR agent), and Rapamycin (an mTOR inhibitor), in children with progressive low-grade gliomas who have failed initial conventional treatment. In addition to evaluating the toxicity of this drug regimen, the potential efficacy of the regimen will be assessed.

Conditions

Low-grade Gliomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Tarceva and Rapamycin

Tarceva will be administered once a day for 28 days without interruption. THen Rapamycin will be administered, orally twice daily, in combination with the Tarceva for the remainder of the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• children less than 21 years of age, with or without neurofibromatosis, with recurrent low-grade gliomas.
• patients with or without NF1 must have failed some form of conventional therapy, radiotherapy, or chemotherapy (carboplatin/vincristine) to be eligible, including those treated wtih initial surgery. Patients do not have to have received radiotherapy to be eligible.
• children with all types of histologically proven low-grade gliomas will be eligible; re-operation at the time of recurrence is not mandatory for entry on study.
• patients with intrinsic brain lesions, believed neuroradiographically consistent with a low-grade glial tumor, with neurofibromatosis type 1 can be treated without histological confirmation.
• patients without neurofibromatosis type 1 must have histological confirmation of a low-grade glial tumor prior to entry on study.
• patients must have a Karnofsky score of greater than or equal to 50% for children greater than 10 years of age, or a Lansky score of greater than or equal to 50% for patients less than 10 years of age.
• patients who are unable to walk because of paralysis, but who are able to use a wheelchair, will be considered ambulatory for purposes of assessing performance score.
• patients must have a life expectancy of at least 12 weeks.
• patients must be able to swallow medication in tablet form.
• patients must have adequate organ function, including: peripheral ANC of greater than 1,000/microliters; a platelet count of greater than 100,000/microliters; hemoglobin of greater than 8 gms,dl (pRBC transfusions of allowed to maintain hemoglobin > 8 g/dl)
• patients must have adequate renal function, which is defined as a normal serum creatinine for age
• patients must have adequate liver function, as defined as a total bilirubin or less than 1.5 times the upper limit of normal for age, and an SGPT (ALT) of less than 2.5 times the upper limit of normal for age
• patients must have had a MR scan within 3 weeks of starting treatment
• all patients, and/or their parents or legal guardian, must sign a recent informed consent
• all institutional, FDA, and NCI requirements for human study must be met.

Exclusion Criteria

• patients must not have any other active tumors.
• patients with uncontrolled infection are excluded.
• patients who have previously received Tarceva or Rapamycin are excluded.
• patients on antiepileptics and/or corticosteroids are allowed on study as long as they have been on a stable or weaning dose for 7 days prior to study initiation (defined as first day of treatment).

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: collaborator

Roger Packer

OTHER

Sponsor Role: lead

Responsible Party

Roger Packer

Senior Vice President, Center for Neuroscience and Behavioral Medicine;

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Children's Research Institute

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

4104

Identifier Type: -

Identifier Source: org_study_id