Status:
COMPLETED
PH I Addition of Farnesyl Transferase Inhibitor to Temozolomide for Pts w Gr 3 & 4 Malignant Gliomas
Lead Sponsor:
Duke University
Collaborating Sponsors:
Schering-Plough
Conditions:
Gliosarcoma
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Objectives: To determine maximum tolerated dose of farnesyl transferase inhibitor, SCH 66336, when administered w TEMODAR®. To characterize any toxicity associated w combo of farnesyl transferase in...
Detailed Description
2 separate strata accrued independently of each other: Stratum1-Patients receiving Dilantin, Tegretol / phenobarbital. Stratum2-Patients on anti-convulsants other than Dilantin, Tegretol / phenobarbit...
Eligibility Criteria
Inclusion
- Pts with MG histologically confirmed at diagnosis, who were treated previously with conventional external beam radiation \& with or without chemotherapy, \& have stable disease, recurrence or relapse at the time of enrollment.
- Age \> or = to 18 years.
- Patients who have had previous surgical resection(s) are eligible.
- Interval of at least 3 weeks between prior surgical resection, 2 weeks between prior radiotherapy, or 4 weeks between prior chemotherapy, unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy.
- Karnofsky performance score \> or = to 60%.
- Adequate hematologic, renal \& liver function as demonstrated by lab values performed within 14 days, inclusive, prior to administration of chemotherapy:
- ANC \> or = to 1500/mm3
- Platelet count \> or = to 100,000/mm3
- Hemoglobin \> or = to 10 gm/dL
- BUN and serum creatinine \<1.5 times upper limit of lab normal
- Total serum bilirubin \<1.5 times upper limit of lab normal
- SGOT \<2.5 times upper limit of lab normal
- Patients must have recovered from any effects of major surgery.
- Patients must have life expectancy of greater than 12 weeks.
- Patients or legal guardian must give written, informed consent.
Exclusion
- Patients requiring immediate radiation therapy.
- Patients who have not recovered from surgery.
- Patients who are not neurologically stable for 2 weeks prior to study entry.
- Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction).
- Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
- Known HIV positivity or AIDS-related illness.
- Pregnant or nursing women.
- Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
- Men who are not advised to use an effective method of contraception.
- Patients taking immuno-suppressive agents other than prescribed corticosteroids.
- Patients previously treated with farnesyl transferase inhibitors.
- Patients with significant QTc prolongation (\>500 msec)as evaluated by an EKG.
- Patients having presented prior disease progression on TEMODAR.
- Patients having presented any grade 4 hematologic toxicity or grade 3 or 4 non-hematologic toxicity on TEMODAR in the past.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00612651
Start Date
October 1 2005
End Date
June 1 2011
Last Update
February 20 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710