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Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Michael Prados, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00823459
First received: January 13, 2009
Last updated: January 17, 2014
Last verified: January 2014

January 13, 2009
January 17, 2014
January 2009
December 2014   (final data collection date for primary outcome measure)
To determine progression-free survival at 6 months associated with use of RAD001 [ Time Frame: survival ] [ Designated as safety issue: No ]
To determine progression-free survival at 6 months associated with use of RAD001
Complete list of historical versions of study NCT00823459 on ClinicalTrials.gov Archive Site
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Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma
Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma

A single-arm, one-stage phase II trial of RAD001 will be undertaken. Sixty patients will be enrolled. The target population will be patients with a diagnosis of low-grade glioma who experience a recurrence and who undergo a biopsy or subtotal resection at the time of recurrence with pathologic evidence of recurrent glioma. The purpose of this study is to accrue patients to evaluate a pharmacologic agent. The study drug RAD001 will be self-administered (by the patients themselves). RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Low-grade Glioma
  • Astrocytoma
  • Oligodendroglioma
  • Mixed Oligoastrocytoma
Drug: RAD001
RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.
Other Name: Certican
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a Karnofsky performance status of > 60
  • Patients must have a life expectancy > 8 weeks
  • Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb >9 g/dL
  • Adequate liver function as shown by:
  • serum bilirubin ≤ 1.5 x ULN
  • INR < 1.3 (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for > 2 weeks at the time of registration)
  • ALT and AST ≤ 2.5x ULN
  • Adequate renal function: serum creatinine ≤ 1.5 x ULN
  • Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
  • Patients must have histologically proven intracranial low-grade glioma at initial diagnosis.
  • Patients must have unequivocal evidence for tumor recurrence or progression by histology as determined by review of pathology by an attending neuro-pathologist at UCSF
  • If most recent histology shows progression to high grade glioma, patients must have had prior radiotherapy in order to be eligible
  • Paraffin-embedded sections of tissue acquired from surgery at the time of suspected recurrence must be available for analysis
  • Patients must have evidence for tumor recurrence or progression by MRI as determined by radiographic review of images by an attending neuro-oncologist or neuro-radiologist at UCSF
  • An MRI must be used throughout the period of protocol treatment for tumor measurement
  • Patients may have had treatment (including radiotherapy) for any number of relapses prior to this recurrence
  • Patients must be at least 4 weeks from the completion of any radiation therapy
  • Patients must be less than 4 months from the surgical procedure for this recurrence
  • Patients must have recovered from the toxic effects of prior therapy:

    • 4 weeks from any investigational agent.
    • 4 weeks from prior cytotoxic therapy (except 6 weeks from nitrosoureas, 3 weeks from procarbazine, 3 weeks from vincristine)
    • 3 weeks for non-cytotoxic or biologic agents e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc

Exclusion Criteria:

  • Patients, who have not recovered from the side effects of a major surgery or significant traumatic injury or patients that may require major surgery during the course of the study
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids, and treatment with low dose Decadron (£ 6mg daily) are allowed.
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  • Other than surgery, patients may not have therapy for this recurrence (including radiation). Supportive care such as steroids or anti-epileptics does not constitute treatment of recurrence
  • Patients must not be on an enzyme inducing antiepileptic agent within 5 days of starting protocol therapy
  • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
  • Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
  • Uncontrolled brain or all leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Symptomatic congestive heart failure of New York heart Association Class III or IV
  • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
  • Impaired lung function: Oxygen saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is ≤ 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility.
  • uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
  • active (acute or chronic) or uncontrolled severe infections
  • liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • A known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
  • Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
  • Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
Both
18 Years and older
No
Contact: Thelma Munoz 415 353 2523 munozt@neurosurg.ucsf.edu
Contact: Ashley DeSilva 415-353-2653 DeSilvaAA@neurosurg.ucsf.edu
United States
 
NCT00823459
08109
Yes
Michael Prados, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Susan Chang, MD University of California, San Francisco
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP