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

Primary Purpose

Glioblastoma, Brain Tumor

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring sunitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed glioblastoma
18 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

Exclusion Criteria:

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
Concomitant use of ketoconazole and other agents known to induce CYP3A4
Pregnancy or breastfeeding
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib

Sites / Locations

Massachusetts General Hospital
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00864864

First Posted

March 17, 2009

Last Updated

July 6, 2016

Sponsor

Massachusetts General Hospital

Collaborators

Brigham and Women's Hospital, Dana-Farber Cancer Institute, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00864864

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Brigham and Women's Hospital, Dana-Farber Cancer Institute, Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Participants will take the study drug, sunitinib, for 7 days prior to their surgery. The surgery is part of the routine care for glioblastoma and will be performed on Day 8. The study drug is supplied in capsule form and is to be taken at home. On Day 7 participants will come to the clinic and have the following tests and procedures performed: Neurological and physical examination; vital signs; and blood samples. On day 9 (the day after the surgery) an MRI scan will be performed. Fourteen days after the participants surgery (Day 22), they will restart sunitinib treatment. They will take the study drug once a day for 4 weeks followed by a 2 week rest period (no study drug treatment). This 6 week period is called a cycle of study treatment. Participants can continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side-effects. Before each new cycle of study treatment (once every 6 weeks) the participant will come into the clinic for the following tests: Neurological and physical examination; vital signs; blood sample; urine sample; MRI scan of the brain (done every even cycle).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, Brain Tumor

Keywords

sunitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sunitinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

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

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed glioblastoma 18 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 Exclusion Criteria: 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 Concomitant use of ketoconazole and other agents known to induce CYP3A4 Pregnancy or breastfeeding History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Plotkin, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

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

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