Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

Summary

This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Immunotherapy with bevacizumab and cetuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bevacizumab and temsirolimus work better when given alone or with valproic acid or cetuximab in treating patients with a malignancy or other disease that is not cancerous.

Timeline

Start

2012-10-16

Primary completion

2026-05-08

Completion

2026-05-08

Publications

• Piha-Paul SA, Tseng C, Thompson E, Stafford RJ, Le H, Kang L, Fu S, Tsimberidou A, Blumenschein G, Ahnert JR, Slopis JM, Hong D, Naing A, Meric-Bernstam F, Ng CS, Westin S, Sood AK. Phase I study of bevacizumab and temsirolimus combination therapy in advanced malignancies: safety, efficacy, and ovarian cancer expansion. Oncologist. 2026 Feb 5;31(3):oyaf413. doi: 10.1093/oncolo/oyaf413.
• Nelson BE, Tsimberidou AM, Fu X, Fu S, Subbiah V, Sood AK, Rodon J, Karp DD, Blumenschein G, Kopetz S, Pant S, Piha-Paul SA. A Phase I Trial of Bevacizumab and Temsirolimus in Combination With Valproic Acid in Advanced Solid Tumors. Oncologist. 2023 Dec 11;28(12):1100-e1292. doi: 10.1093/oncolo/oyad158.

Drugs

Indications