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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01552434
Phase
PHASE1
Status
Terminated

Conditions

  • 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
  • Stage IVB Pharyngeal Cancer
  • Stage IVC Pharyngeal Cancer
  • Thyroid Gland Neoplasm

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Cetuximab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Optional correlative studies
  • Pharmacological Study — OTHER
    Optional correlative studies
  • Temsirolimus — DRUG
    Given IV
  • Valproic Acid — DRUG
    Given PO

Study Details

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.

Key Dates

First listed
Mar 13, 2012
Start date
Oct 16, 2012
Status verified
May 2026
Primary completion
May 8, 2026
Completion
May 8, 2026

Study Design

Enrollment
154 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (temsirolimus, bevacizumab, cetuximab)
    Patients receive temsirolimus 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 60-120 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group II (temsirolimus, bevacizumab, valproic acid)
    Patients receive temsirolimus and bevacizumab as in Group I and valproic acid PO on days 1-7 and 15-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group III (temsirolimus, bevacizumab)
    Patients receive temsirolimus and bevacizumab as in Group I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) of bevacizumab, defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) [ Time Frame: 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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