Status:
COMPLETED
Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genentech, Inc.
OSI Pharmaceuticals
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective: To determine the 6-month progression free survival of patients with recurrent glioblastoma multiforme (GBM) treated with Erlotinib plus Sirolimus. Secondary objectives: To furthe...
Detailed Description
The primary objective of this study will be to determine the 6-month progression free survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus. This is an exploratory, single-arm...
Eligibility Criteria
Inclusion
- Pts have confirmed diagnosis of recurrent primary WHO grade IV malignant glioma (MG). Pts w recurrent disease whose diagnostic pathology confirmed GBM will not need re-biopsy. Pts w prior low-gr glioma / anaplastic glioma are eligible if histologic assessment demonstrates transformation to GBM
- Age \>18 yrs
- Interval of \>2 wk between prior surgical resection
- Interval of \>12 wks between prior external-beam radiation therapy (XRT) unless there is either: histopathologic confirmation of recurrent tumor; new enhancement on MRI outside of XRT treatment field; / progressive radiographic changes after XRT/temo as well as after adjuvant, post-XRT temo
- Interval of \>4 wks between chemo \& enrollment on protocol unless: unequivocal evidence of tumor progression; \& pt has recovered fully from all toxicity associated w prior surgery, XRT/chemo. Pts treated w chemo agents such as VP-16 who would normally be retreated after shorter intervals may be treated at usual starting time even if \<4 wks from last prior dose chemo
- Karnofsky performance score \>= 70 percent
- Hematocrit \>29 percent, absolute neutrophil count (ANC) \>1,500 cells/microliter, platelets \>100,000 cells/microliter
- Serum creatinine \<1.5 mg/dl, serum glutamic oxaloacetic transaminase (SGOT) \& bilirubin \<1.5 x upper limit of normal (ULN); fasting plasma triglyceride \& cholesterol \< gr1
- For pts on corticosteroids, dose should not be increasing for \>7 days prior to baseline Gd-MRI of brain if medically appropriate
- Pts in enzyme inducing antiepileptic drug cohort must be on stable dose of p450-inducing EIAED for \>2 wks. Pts in non-EIAED cohort must not receive any p450-EIAED for \>2 wks prior to \& during participation in trial
- Signed informed consent approved by Institutional Review Board (IRB) prior to pt entry
- If sexually active, pts will take contraceptive measures for duration of treatments \& for 3 months following discontinuation of Erlotinib
- Pts who have had prior bevacizumab are eligible however interval of \>6 weeks must have elapsed since their last dose
Exclusion
- Prior mammalian target of rapamycin (mTOR) directed therapy
- Prior epidermal growth factor receptor (EGFR)-directed therapy
- Female pts are pregnant/breast feeding, or adults of reproductive potential not employing effective method of birth control. Women of childbearing potential must have negative serum pregnancy test \<72 hours prior to administration of Erlotinib
- Co-medication that may interfere w study results
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hyperlipidemia not controlled w medication, psychiatric illness/social situations that would limit compliance w study requirements,/disorders associated w significant immunocompromise
- Acute/chronic liver disease
- Impairment of GI function/GI disease that may significantly alter absorption of Erlotinib
- Pts who have received investigational drugs \<4 wks prior to entry on study or who have not recovered from toxic effects of such therapy
- Pts who have received biologic, immunotherapeutic/cytostatic agents \<1 wk prior to entry on study/have not recovered from toxic effects of such therapy
- Pt is \<5 yrs free of another primary malignancy except: if other primary malignancy is not currently clinically significant/requiring active intervention,/if other primary malignancy is basal cell skin cancer/cervical carcinoma in situ. Existence of any other malignant disease is not allowed
- Pts have had any surgery other than resection of brain tumor \<2 wks prior to entry on study/have not recovered from side effects of such therapy
- Pts unwilling to/unable to comply w protocol
- Pts w acute/chronic renal insufficiency/those w acute renal insufficiency of any severity due to hepato-renal syndrome/in peri-operative liver transplantation period
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00672243
Start Date
April 1 2007
End Date
December 1 2009
Last Update
August 7 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710