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

18 Years
Open (Enrolling)
Glioblastoma, Brain Tumor

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Trial Information

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

- 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).

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Scott Plotkin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

May 2012

Related Keywords:

  • Glioblastoma
  • Brain Tumor
  • sunitinib
  • Brain Neoplasms
  • Glioblastoma



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617