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.

Conditions

• Stage IVB Pharyngeal Cancer
• Stage IVC Pharyngeal Cancer
• Advanced Malignant Neoplasm
• Castleman Disease
• Digestive System Carcinoma
• Erdheim-Chester Disease
• Lip and Oral Cavity Carcinoma
• Lymphangioleiomyomatosis
• Malignant Endocrine Neoplasm
• Malignant Female Reproductive System Neoplasm
• Malignant Male Reproductive System Neoplasm
• Malignant Neoplasm
• Malignant Respiratory Tract Neoplasm
• Malignant Thoracic Neoplasm
• Malignant Urinary System Neoplasm
• Mesothelial Neoplasm
• Metastatic Malignant Neoplasm
• Metastatic Urothelial Carcinoma
• Neurofibromatosis Type 2
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Breast Carcinoma
• Recurrent Childhood Soft Tissue Sarcoma
• Recurrent Digestive System Carcinoma
• Recurrent Female Reproductive System Carcinoma
• Recurrent Male Reproductive System Carcinoma
• Recurrent Malignant Neoplasm
• Recurrent Pharyngeal Carcinoma
• Recurrent Thyroid Gland Carcinoma
• Refractory Malignant Neoplasm
• Soft Tissue Neoplasm
• Stage III Breast Cancer AJCC v7
• Stage III Pharyngeal Cancer
• Stage IIIA Breast Cancer AJCC v7
• Stage IIIB Breast Cancer AJCC v7
• Stage IIIC Breast Cancer AJCC v7
• Stage IV Breast Cancer AJCC v6 and v7
• Stage IV Pharyngeal Cancer
• Stage IVA Pharyngeal Cancer
• Thyroid Gland Neoplasm

Interventions

BIOLOGICAL

Bevacizumab

Given IV

BIOLOGICAL

Cetuximab

Given IV

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

OTHER

Pharmacological Study

Optional correlative studies

DRUG

Temsirolimus

Given IV

DRUG

Valproic Acid

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Sarina A Piha-Paul · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-16

Primary Completion

2026-05-08

Completion

2026-05-08

FDA Drug

Yes

Countries

• United States

Study Locations