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

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ClinicalTrials.gov Identifier: NCT00901849
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : September 16, 2014
Children's National Research Institute
Information provided by (Responsible Party):
Roger Packer, Children's National Research Institute

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.

Condition or disease Intervention/treatment Phase
Low-grade Gliomas Drug: Tarceva and Rapamycin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Tarceva and Rapamycin For Recurrent Low-Grad Gliomas in Children With or Without Neurofibromatosis Type 1 (NF1)
Study Start Date : May 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2012

Intervention Details:
  • Drug: 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.

Primary Outcome Measures :
  1. Participants will remain on the trial for one year if benefiting from drug as demonstrated by radiographic evaluation and clinical evaluation. [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • pregnancy or breast feeding is an exclusion criteria, as the potential mutagenicity and cytotoxicity of these drugs in developing fetuses are unknown. A pregnancy test must be obtained in females who are postmenarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901849

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United States, District of Columbia
Children's Research Institute
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Roger Packer
Children's National Research Institute
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Responsible Party: Roger Packer, Senior Vice President, Center for Neuroscience and Behavioral Medicine;, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT00901849    
Other Study ID Numbers: 4104
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Neurofibromatosis 1
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Erlotinib Hydrochloride
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents