NCT02238496

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

Completed Phase 1 Last updated 25 May 2023

What this trial tests

Phase 1 trial testing Cytoreductive surgery in Brain Tumor, Recurrent in 10 participants. Completed in 14 February 2021.

Timeline

8 December 2014

Primary endpoint
27 October 2017

14 February 2021

Quick facts

Lead sponsor	Andrew B Lassman, MD
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	8 December 2014
Primary completion	27 October 2017
Estimated completion	14 February 2021
Sites	2 locations across United States

Drugs / interventions tested

• Cytoreductive surgery
• Perifosine — full drug profile →
• Temsirolimus (temsirolimus) — full drug profile →

Conditions studied

• Brain Tumor, Recurrent — all drugs for Brain Tumor, Recurrent →
• Glioblastoma — all drugs for Glioblastoma →
• Anaplastic Astrocytoma — all drugs for Anaplastic Astrocytoma →
• Anaplastic Oligodendroglioma — all drugs for Anaplastic Oligodendroglioma →

Sponsor

Andrew B Lassman, MD

Who can join

18 and older, any sex, with Brain Tumor, Recurrent or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Challenges and Opportunities in Treating Glioblastoma.
   Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
2. Glioma targeted therapy: insight into future of molecular approaches.
   Yang K, Wu Z, Zhang H, Zhang N, et al · · 2022 · cited 518× · PMID 35135556 · DOI 10.1186/s12943-022-01513-z
3. Metabolic reprogramming in macrophage responses.
   Liu Y, Xu R, Gu H, Zhang E, et al · · 2021 · cited 428× · PMID 33407885 · DOI 10.1186/s40364-020-00251-y
4. PI3K/Akt/mTOR signaling pathway and targeted therapy for glioblastoma.
   Li X, Wu C, Chen N, Gu H, et al · · 2016 · cited 406× · PMID 26967052 · DOI 10.18632/oncotarget.7961
5. AKT in cancer: new molecular insights and advances in drug development.
   Mundi PS, Sachdev J, McCourt C, Kalinsky K. · · 2016 · cited 200× · PMID 27232857 · DOI 10.1111/bcp.13021
6. Maximising the potential of AKT inhibitors as anti-cancer treatments.
   Brown JS, Banerji U. · · 2017 · cited 184× · PMID 27919797 · DOI 10.1016/j.pharmthera.2016.12.001
7. Pathogenetic Features and Current Management of Glioblastoma.
   Nguyen HM, Guz-Montgomery K, Lowe DB, Saha D. · · 2021 · cited 42× · PMID 33670551 · DOI 10.3390/cancers13040856
8. The role of metabolic ecosystem in cancer progression - metabolic plasticity and mTOR hyperactivity in tumor tissues.
   Sebestyén A, Dankó T, Sztankovics D, Moldvai D, et al · · 2021 · cited 35× · PMID 35029792 · DOI 10.1007/s10555-021-10006-2