Clinical trial · Interventional
PH I Addition of Farnesyl Transferase Inhibitor to Temozolomide for Pts w Gr 3 & 4 Malignant Gliomas
A Phase I Trial of the Addition of the Farnesyl Transferase Inhibitor, SCH 66336, to Temodar for Patients With Grade 3 and 4 Malignant Gliomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temodar and SCH 66336 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- enzyme-inducing anti-epileptic drugs (EIAEDs)
- description
- Patients receiving enzyme-inducing anti-epileptic drugs (EIAEDs)such as carbamazepine, phenobarbitol, phenytoin, phosphenytoin, oxcarbamazepine, primadone)
- interventionNames
- Drug: Temodar and SCH 66336
- type
- OTHER
- label
- no enyzme-inducing anti-epileptic drugs
- description
- Patients on non CYP3A4-inducing anti-convulsants or patients not on any anti-convulsants.
- interventionNames
- Drug: Temodar and SCH 66336
Primary outcomes (1)
- measure
- Dose-limiting toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available