Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT00612651
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00612651
Study Brief:
Protocol Section:
NCT00612651