PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma
There are three arms to this study (A, B and C) The purpose of this research study during Arm A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one reason that chemotherapy drugs might not be effective is that the drug may not be able to get into the brain tumor and kill the cancer cells. We will determine how much PF-00299804 gets into the brain tumor by obtaining a sample of the tumor from the surgery that the participant already has scheduled. The purpose of this research study during Arm B and C, is to determine how well PF-00299804 works in killing cancer cells. PF-00299804 works by binding to specific proteins found on the surface of some cancer cells that promote a growth signal. Blocking this signal from reaching its target on the cancer cells may slow or stop the cancer from growing.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Phase 2 Trial of Orally Administered PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma (GBM)|
- Progression-Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess progression-free survival at six months in patients with recurrent GBM and EGFR amplification in archival tumor material who are treated with continuous daily dosing of PF-00299804 (Arm B)
- Ability of PF-00299804 to cross the blood-brain barrier [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess the ability of PF-00299804 to cross the blood-brain barrier in GBM patients who are candidates for surgical re-section in Arm A.
- Safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Evaluate the safety and tolearbility of orally administered PF-00299804 on a continuous dosing schedule in patients with recurrent GBM.
- Anti-tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess anti-tumor response in patients in Arm B
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Patients with Glioblastoma that has returned or grown after chemotherapy or radiation treatment and who will be having a standard operation to remove the tumor.
Taken orally once a day
Experimental: Arm B
Participants with glioblastoma at first recurrence who are not surgical candidates and who have not had prior anti-VEGF therapy.
Taken orally once a day
Experimental: Arm C
Participants with glioblastoma who are not surgical candidates and who are at first recurrence from a therapeutic regimen containing bevacizumab.
Taken orally once a day
- Each treatment cycle lasts four weeks (28 days). There are no breaks from taking PF-00299804 between treatment cycles. Participants will take PF-00299804 once a day for a total of 7 to 9 days before surgery. They will then stop taking PF-00299804 until they have recovered from surgery.
- Once they have recovered from surgery, they will continue to take PF-00299804 once a day until their disease worsens, they experience side effects or they decide to stop study treatment.
- The following tests and procedures will be performed at the time intervals specified: Research blood tests (Day 1 of study drug administration, day of surgery, day 1 of all cycles after surgery, day 14 of the first cycle after surgery); tissue samples (day of surgery); physical and neuro exams (day 1 of all cycles after surgery); skin exam (day 1 of all cycles after surgery and day 14 of the first cycle after surgery).
- An assessment of the tumor by CT or MRI scan will be made within 24 hours after surgery. Another assessment by CT or MRI scan will be made at the end of cycle 2 and then at the end of every even numbered cycle thereafter.
ARM B & C:
- Each treatment cycle lasts four weeks (28 days). There are no breaks from taking PF-00299804 between treatment cycles. Participants will take PF-00299804 orally once a day until their disease worsens, they experience any side effect, or if they decide to stop study treatment.
- Participants will come into the clinic on Day 1 and Day 14 of Cycle 1, and then on Day 1 of all subsequent cycles for some of the following tests and procedures: research blood tests, physical and neuro exams, skin exam, urine test and Patient Reported Outcomes questionnaire.
- An assessment of the participants tumor by CT scan or MRI scans will be done at the end of Cycle 2, 4 and then every other cycle thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112527
|Contact: Tracy T. Batchelor, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Patrick Wen, MD|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Tracy T. Batchelor, MD|
|United States, Michigan|
|Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Principal Investigator: Tom Mikkelsen, MD, FRCP|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator: David Peereboom, M.D.|
|Principal Investigator:||Tracy T. Batchelor, MD||Massachusetts General Hospital|