Status:
TERMINATED
Everolimus and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis From Non-Small Cell Lung Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to ki...
Detailed Description
Phase I is intended to determine the maximum tolerated dose. Study drug will be administered orally, once a day, for 15 days, one day prior to initiation of WBRT at 5 or 10 mg/day during the phase I c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Radiographically confirmed brain metastases with histopathologically confirmed primary non-small cell lung cancer that will benefit from whole-brain radiotherapy
- Must have ≥ 1 measurable intracranial site of disease, according to RECIST criteria, that has not been previously treated with stereotactic radiation
- Must have stable extracranial disease for 4 weeks
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC \> 1,500/mm³
- Platelets \> 100,000/mm³
- Hemoglobin \> 11 g
- BUN ≤ 25 mg
- Serum creatinine \< 1.5 times upper limit of normal (ULN)
- Serum bilirubin ≤ 1.5 times ULN
- Serum transaminases ≤ 2 times ULN (\< 5 times ULN if patient has liver metastases)
- Cholesterol ≤ 300 mg/dL
- Triglycerides ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No other malignancies within the past 3 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinomas of the skin
- No severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study, including any of the following:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia
- Severely impaired lung function (i.e., FEV1 \< 0.8 cc)
- Uncontrolled diabetes as defined by fasting serum glucose ≥ 1.5 times ULN
- Any active (acute or chronic) or uncontrolled infection/disorders
- Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
- Liver disease, such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- No known history of HIV seropositivity
- No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- No active, bleeding diathesis
- No known hypersensitivity to everolimus or other rapamycin (i.e., sirolimus, temsirolimus) or to its excipients
- No history of noncompliance to medical regimens
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from the acute toxicities of any prior therapy
- Prior surgical resection of a brain metastasis allowed
- The extent of surgical resection in patients having prior resection of 1 of multiple metastases shall be documented as a biopsy, subtotal resection, or total resection as described by the operative report and/or post-operative imaging
- At least 3 weeks since prior major surgery or completion of extracranial radiation
- At least 3 weeks since prior and no concurrent systemic anticancer therapy, other than the study medications administered as part of this study protocol
- At least 6 weeks since prior nitrosoureas
- More than 1 week since prior and no concurrent immunization with attenuated live vaccines
- More than 3 weeks since prior chemotherapy
- No prior brain radiotherapy of any form
- No concurrent chronic treatment with systemic steroids or other immunosuppressive agents, except steroids for neurological stability following the diagnosis of brain metastases
- No prior treatment with an mTOR inhibitor
- No concurrent anti-vitamin K medication, except low dose coumarin
- No concurrent drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A
- No other concurrent investigational therapy
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00892801
Start Date
May 1 2009
End Date
February 1 2011
Last Update
March 12 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838