PH I Addition of Farnesyl Transferase Inhibitor to Temozolomide for Pts w Gr 3 & 4 Malignant Gliomas

Completed · Phase 1

Conditions studied: Gliosarcoma, Glioblastoma, Anaplastic Astrocytoma

In brief

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 inhibitor, SCH 66336, \& TEMODAR®. To observe patients for clinical antitumor response when treated with combination of farnesyl transferase inhibitor, SCH 66336, \& TEMODAR®. To assess pharmacokinetics of SCH 66336 for patients on \& not on enzyme inducing antiepileptic drugs.

Key facts

Study ID

NCT00612651

Run by

Duke University

People needed

37

Starts

2005-10-01

Expected to finish

2011-06-01

Last updated by the study team

2013-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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