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

NCT00864864

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioblastoma, Brain Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Glioblastoma, Brain TumorSunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
NCT00864864
  1. Boston, Massachusetts
  2. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
Official Title  ICMJE Pilot Study of Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma
  • Brain Tumor
Intervention  ICMJE Drug: Sunitinib
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
Study Arms  ICMJE Experimental: Sunitinib
Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2016)
8
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2009)
12
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00864864
Other Study ID Numbers  ICMJE 06-307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott Randall Plotkin, MD, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Pfizer
Investigators  ICMJE
Principal Investigator:Scott Plotkin, MD, PhDMassachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP