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Signal Transduction Inhibitor
Surgical Cohort - cytoreductive surgery for Brain Cancer
Phase 1
Waitlist Available
Led By Andrew B. Lassman, MD
Research Sponsored by Andrew B Lassman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed intracranial glioblastoma (GBM), including sub variants
At least 15 unstained slides or at least 1 tissue blocks must be collected from at least one prior surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months from start of treatment
Awards & highlights
Study Summary
This trial is testing whether temsirolimus and perifosine can effectively treat brain tumors that have continued to grow after previous treatment.
Eligible Conditions
- Brain Cancer
- Glioblastoma
- Gliomas
- Anaplastic Astrocytoma
- Oligodendroglioma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months from start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate
Secondary outcome measures
Median Overall Survival Rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: Surgical Cohort - cytoreductive surgeryExperimental Treatment3 Interventions
Cytoreductive surgery planned (surgical cohort). After post-operative standard evaluations, patients will resume therapy. After anti-emetic prophylaxis, patients will receive the first divided dose of the perifosine loading dose after recovery from surgery. Patients will be observed for at least 30 minutes to ensure there has been adequate anti-emetic prophylaxis, and then patients will receive temsirolimus administered over 30-60 minutes IV. The remaining divided doses of the perifosine loading dose will then be administered. Patients will then return weekly for infusion of temsirolimus over 30-60 minutes IV. Dosing will be continuous although for the purposes of evaluation, a cycle will be defined as 4 weeks (28 days).
Group II: Medical Cohort - no cytoreductive surgeryExperimental Treatment2 Interventions
No-Cytoreductive surgery planned (medical cohort). After anti-emetic prophylaxis, patients will receive the first divided dose of the perifosine loading dose. Patients will be observed for at least 30 minutes to ensure there has been adequate anti-emetic prophylaxis, and then patients will receive temsirolimus administered over 30-60 minutes IV. The remaining divided doses of the perifosine loading dose will then be administered. Patients will then return weekly for infusion of temsirolimus over 30-60 minutes IV. Dosing will be continuous although for the purposes of evaluation, a cycle will be defined as 4 weeks (28 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoreductive surgery
2013
Completed Phase 3
~180
Perifosine
2006
Completed Phase 3
~2080
Temsirolimus
2008
Completed Phase 2
~1940
Find a Location
Who is running the clinical trial?
Andrew B Lassman, MDLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
AEterna ZentarisIndustry Sponsor
41 Previous Clinical Trials
5,257 Total Patients Enrolled
PfizerIndustry Sponsor
4,562 Previous Clinical Trials
10,907,111 Total Patients Enrolled
Frequently Asked Questions
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