Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma
Verified January 2014 by University of California, San Francisco
Information provided by (Responsible Party):
Michael Prados, University of California, San Francisco
First received: January 13, 2009
Last updated: January 17, 2014
Last verified: January 2014
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma
Primary Outcome Measures:
- To determine progression-free survival at 6 months associated with use of RAD001 [ Time Frame: survival ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823459
University of California, San Francisco
||Susan Chang, MD
||University of California, San Francisco
No publications provided
||Michael Prados, Professor, University of California, San Francisco
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 13, 2009
||January 17, 2014
||United States: Food and Drug Administration
Keywords provided by University of California, San Francisco:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Physiological Effects of Drugs