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

    Not Recruiting
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 19 August 2022
absolute neutrophil count
valproic acid
neutrophil count
tumor cells
primary cancer
antineoplastic agents
antibody therapy
other disease
anticancer agents
type 2 neurofibromatosis


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.



I. To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of treatment with bevacizumab and temsirolimus in combination and plus valproic acid or cetuximab.


I. Preliminary descriptive assessment of anti-tumor efficacy of each combination.

II. Preliminary assessment of the pharmacokinetic, pharmacodynamic markers of target inhibition and correlates of response (optional).

OUTLINE: This is a dose-escalation study of bevacizumab and temsirolimus. Patients are assigned to 1 of 3 treatment groups.

GROUP I: Patients receive temsirolimus intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22; bevacizumab IV over 30-90 minutes on days 1 and 15; and cetuximab IV over 1-2 hours on days 1, 8, 15, and 22.

GROUP II: Patients receive temsirolimus and bevacizumab as in Group I and valproic acid orally (PO) daily on days 1-7 and 15-21.

GROUP III: Patients receive temsirolimus and bevacizumab as in Group I.

In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Condition Castleman's Disease, urinary tract neoplasm, Urologic Cancer, Soft tissue tumor, Thyroid Adenoma, Thyroid Cancer, Cancer, Cancer/Tumors, Neoplasms, Cancer (Pediatric), Ewing's Family Tumors, Cancer, Erdheim-Chester Disease, Bilateral acoustic neurofibromatosis, Lymphangiomyomatosis, Lymphangioleiomyomatosis, Lymphoproliferative Disorder, Lymphoproliferative disorders, Mesothelioma, Cancer/Tumors, Recurrent Adult Soft Tissue Sarcoma, Stage IV Breast Cancer AJCC v6 and v7, Advanced Cancer, Advanced Cancers, Metastatic Malignant Neoplasm, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Recurrent Breast Cancer, Ewing's Family Tumors, Recurrent Breast Carcinoma, Recurrent Thyroid Gland Carcinoma, Gynecologic Cancer, Advanced Malignant Neoplasm, Thoracic Cancer, Malignant Female Reproductive System Neoplasm, Refractory Cancer, Refractory Malignant Neoplasm, Recurrent Malignant Neoplasm, Cancer Refractory, Metastatic Urothelial Carcinoma, Recurrent Childhood Soft Tissue Sarcoma, Cancer, Metastatic, Cancer (Pediatric), Recurrent Thyroid Cancer, Digestive System Carcinoma, Lip and Oral Cavity Carcinoma, Malignant Endocrine Neoplasm, Malignant Male Reproductive System Neoplasm, Malignant Respiratory Tract Neoplasm, Malignant Thoracic Neoplasm, Recurrent Digestive System Carcinoma, Recurrent Female Reproductive System Carcinoma, Recurrent Male Reproductive System Carcinoma, Recurrent Pharyngeal Carcinoma, Stage III Pharyngeal Cancer, Stage IV Pharyngeal Cancer, Stage IVA Pharyngeal Cancer, Stage IVB Pharyngeal Cancer, Stage IVC Pharyngeal Cancer, Lymphangioleiomyomatosis, Neoplasms, Thyroid Cancer, Lymphoproliferative disorders, Urologic Cancer, primary cancer, primary malignant neoplasm, cancer advanced, soft tissue tumour, soft tissue tumors, endocrine cancer, malignancy, cancers, malignancies, malignant tumor, malignant tumors, neurofibromatosis type 2, neurofibromatosis type ii, type 2 neurofibromatosis, urinary tract cancer
Treatment Cetuximab, laboratory biomarker analysis, bevacizumab, valproic acid, pharmacological study, Temsirolimus
Clinical Study IdentifierNCT01552434
SponsorM.D. Anderson Cancer Center
Last Modified on19 August 2022

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