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A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma

NCT00606008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-11-19

Study results available
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Summary

We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).

The purposes of this study are:

* To see if Sutent has any change on the patient and their cancer.
* To see if Sutent will slow or stop the growth of their tumor.
* To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer.

Conditions

Interventions

DRUG

Sunitinib Malate

Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Edward Pan, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00606008 on ClinicalTrials.gov