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Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors

NCT00667394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-11-05

Study results available
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Summary

Background:

In order to survive, brain tumors must have a network of blood vessels to supply it with oxygen and nutrients. The tumors produce substances that enable new blood vessels to form.

Tandutinib and Bevacizumab are experimental drugs that may prevent new blood vessel formation and thereby slow or stop tumor growth in the brain.

Objectives:

To determine the safety and side effects of Tandutinib in combination with Bevacizumab in patients with brain tumors.

To evaluate the response of brain tumors to treatment with Tandutinib and Bevacizumab.

Eligibility:

Patients 18 years of age and older with a malignant brain tumor for whom standard treatments (surgery, radiation and chemotherapy) are no longer effective.

Design:

Patients receive treatment in 4-week cycles as follows: Tandutinib by mouth twice a day every day and intravenous (through a vein) infusions of Bevacizumab over 90 minutes (or less if well tolerated) every 2 weeks. Treatment may continue for up to 1 year, and possibly longer, as long as there are no signs of tumor growth or serious treatment side effects.

Patients are evaluated with magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) scans before starting treatment and then periodically to determine the response to treatment.

Patients have physical and neurological examinations every 4 weeks and blood tests every 2 weeks. They complete quality of life questionnaires every 4 weeks.

Conditions

  • Glioblastoma
  • Gliosarcoma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Mixed Oligoastrocytoma

Interventions

BIOLOGICAL

Bevacizumab

Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.

DRUG

MLN-518 (Tandutinib)

Tandutinib 500 mg by mouth daily dose twice a day.

PROCEDURE

Quality-of-life assessment

Forty-five one-sentence questionnaire to assess health related quality of life in patients with brain cancer.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Howard Fine, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00667394 on ClinicalTrials.gov