Status:
COMPLETED
Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may sto...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose(s) and the recommended phase II dose(s) of everolimus when administered with standard-dose temozolomide in patients with newly diagnosed, r...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioblastoma multiforme, meeting 1 of the following criteria:
- Newly diagnosed disease AND meets the following criteria:
- Has undergone prior surgery and radiotherapy with concurrent temozolomide
- No prior chemotherapy except for concurrent low-dose temozolomide given with radiotherapy
- Recurrent or progressive disease after front-line therapy AND meets the following criteria:
- No more than 1 prior chemotherapy regimen in the adjuvant setting
- More than 4 months since last adjuvant treatment
- No prior chemotherapy for recurrence
- Bidimensionally measurable disease, defined as ≥ 1 enhancing lesion ≥ 1 cm x 1 cm by CT scan or MRI, within 21 days of study entry (for patients with recurrent/relapsed disease)
- Patients receiving steroids must be on stable dose for at least 14 days before baseline CT scan or MRI
- Paraffin-embedded sample of primary or metastatic tumor diagnostic specimen must be available
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 120,000/mm³
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No upper gastrointestinal condition or other condition that would preclude compliance with oral medication
- No other prior malignancy except for adequately treated nonmelanoma skin cancer, curatively treated in situ cervical cancer, or other solid tumors curatively treated with no evidence of disease for the past 5 years
- No serious illness or underlying medical condition that would preclude study compliance, including any of the following:
- Significant neurologic or psychiatric disorder that would preclude obtaining informed consent
- Active, ongoing infection
- No known hypersensitivity to everolimus or temozolomide or their components
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 weeks since prior surgery and recovered
- At least 4 weeks since prior radiotherapy
- Concurrent enzyme-inducing antiepileptic drugs allowed
- No concurrent inhibitors of cytochrome 3A4 (e.g., ketoconazole and similar antifungals, erythromycin, or diltiazem)
- No other concurrent experimental drugs, anticancer treatment, or investigational therapy
- No concurrent grapefruit juice
Exclusion
Key Trial Info
Start Date :
March 20 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00387400
Start Date
March 20 2007
End Date
January 6 2012
Last Update
August 4 2023
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
4
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6