NCT02238496

Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas

Pilot Trial of Temsirolimus and Perifosine in Recurrent/Progressive Malignant Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Andrew B Lassman, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effectiveness of a drug called temsirolimus in combination with a drug called perifosine in treating brain tumors that have continued to grow after previous treatment. Temsirolimus is an intravenous drug approved by the FDA for treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain tumors. Perifosine is a pill that has not been approved by the FDA which blocks a messenger that tells cancer cells to grow. Research suggests that combined treatment with both drugs is better than either alone, and that it is reasonably safe.

Detailed description

Malignant gliomas are the most common primary brain tumors, and glioblastoma (GBM) is the most common subtype in adults, representing more than 50% of gliomas. Standard initial treatment for newly diagnosed GBM consists of maximal surgical resection followed by radiotherapy to the tumor bed and chemotherapy with an oral DNA alkylator, temozolomide. However, recurrence is nearly universal despite standard therapy. There is no standard treatment at recurrence. Median survival is about 15 months from diagnosis and 6 months from recurrence. Once patients develop tumor progression, conventional chemotherapy is generally ineffective.

Conditions

• Brain Tumor, Recurrent
• Glioblastoma
• Anaplastic Astrocytoma
• Anaplastic Oligodendroglioma
• Mixed Glioma

Interventions

Type	Name	Description
PROCEDURE	Cytoreductive surgery	Standard of care/routine cytoreductive glioma resection surgery. Arm B only.
DRUG	Perifosine	Perifosine is a pill that has not been approved by the FDA which blocks a messenger that tells cancer cells to grow.
DRUG	Temsirolimus	Temsirolimus is an intravenous drug approved by the FDA for treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain tumors.

Timeline

• Start date: 2014-12-08
• Primary completion: 2017-10-27
• Completion: 2021-02-14
• First posted: 2014-09-12
• Last updated: 2023-05-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study