Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma

NCT00864864 | Completed Early Phase 1 DMC

• 1 other identifier: 06-307
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to determine if sunitinib can get past the blood-brain barrier and into the brain tumor. Sunitinib has shown promising results in treating other cancers and works by blocking blood flow to tumors, which may prevent them from growing further. At the present time, there is no chemotherapy that can cure glioblastoma. The reason why chemotherapy is not fully effective is that many drugs cannot penetrate into brain tumors. This is due to the presence of the blood-brain barrier (BBB) which normally protects the brain from substances in the blood.

Conditions

Glioblastoma; Brain Tumor

Keywords

sunitinib

Outcome Measures

Primary Outcomes (1)

• To assess the ability of sunitinib to achieve a target tumor: plasma ration greater than or equal to 0.2 in patients with recurrent GM.

  3 years

Secondary Outcomes (1)

• To determine if there is an association between growth factor receptor inhibition and tumor phenotype, tumor: plasma ratio of sunitinib and overall survival.

  3 years

Study Arms (1)

Sunitinib

EXPERIMENTAL

Drug: Sunitinib

Interventions

Sunitinib DRUG

Taken orally on days 1-7 prior to surgery and then starting again on Day 22 for 4 weeks followed by a 2 week rest period

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed glioblastoma
• years of age or older
• Karnofsky Performance Status 60 or greater
• Patient must be on no anti-epileptic drugs (AED) or AED that are non-enzyme inducing (NEIAED)
• There is no limit to the number of prior chemotherapy regimens
• No concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast. Patients with prior malignancies must be disease-free for 5 years or more
• Mini-mental status examination score of 15 or less
• Resolution of all acute toxic effect of prior chemotherapy, radiotherapy, or surgical procedures to grade 1 or less
• Adequate organ function as outlined in the protocol

You may not qualify if:

• Major surgery within 4 weeks of starting the study treatment
• Radiation therapy within 3 months of starting the study treatment
• Chemotherapy within 4 weeks (within 6 weeks for nitrosoureas) prior to entering the study
• Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials are allowed
• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure. stroke or transient ischemic attack, or pulmonary embolism
• Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
• Prolonged QTc interval on baseline EKG
• Hypertension that cannot be controlled by medications
• Patients must not have a known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhages in the past
• Patients must be on therapeutic doses of anti-coagulants or anti-platelet agents while taking sunitinib
• Grade 3 systemic hemorrhage within 4 weeks fo starting the study treatment
• Patients whose MRI scan shows clinically significant intratumoral or peritumoral hemorrhage
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or active infection
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator
• Pfizer: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Scott Plotkin, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: May 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2013
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

US (2)