Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Gliosarcoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Channel Blockers

Anticonvulsants

Analgesics

Central Nervous System Depressants

Psychotropic Drugs

Central Nervous System Stimulants

Temozolomide

Phenytoin

Carbamazepine

Phenobarbital

Oxcarbazepine

Lonafarnib

Convulsants

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Patients receiving enzyme-inducing anti-epileptic drugs (EIAEDs)such as carbamazepine, phenobarbitol, phenytoin, phosphenytoin, oxcarbamazepine, primadone)

Patients on non CYP3A4-inducing anti-convulsants or patients not on any anti-convulsants.

2 separate strata accrued independently: Stratum 1-pts receiving CYP3A4-inducing anticonvulsants. Stratum 2-pts on non CYP3A4-inducing anticonvulsants or pts not on any anti-convulsants. Each strata treated \& escalated independent of each other. Temozolomide administered orally at dose of 150 mg/m2 daily for 5 days, at bedtime, for 1st cycle \& escalated to 200 mg/m2 daily for 5 days, at bedtime during subsequent cycles if tolerated. Treatment cycles repeated every 4wks following doses of Temozolomide from previous cycle. SCH 66336 administered orally twice daily, approximately every 12hrs. Except as specifically noted, pts advised to take capsules wh morning \& evening meals, with approximately 240ml of non-carbonated water. Initial doses will be 125mg BID for stratum 1 \& 75mg BID for stratum2. Treatment cycles repeated every 4 wks following dose of Temozolomide from previous cycle.

Temodar and SCH 66336

Annick Desjardins, MD

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.

2 separate strata accrued independently of each other: Stratum1-Patients receiving Dilantin, Tegretol / phenobarbital. Stratum2-Patients on anti-convulsants other than Dilantin, Tegretol / phenobarbital / Patients not on any anti-convulsants. Each stratum treated \& escalated independent of each other. Temozolomide administered orally at dose of 150mg/m2 daily for 5 days, at bedtime, for 1st cycle \& escalated to 200mg/m2 daily for 5 days, at bedtime during subsequent cycles if tolerated. Treatment cycles may be repeated every 4 weeks following doses of Temozolomide from previous cycle. SCH 66336 administered orally twice day, approximately every 12hrs. Initial doses will be 125mg BID for stratum 1 \& 75mg for stratum 2. Treatment cycles may be repeated every 4 weeks following dose of Temozolomide from previous cycle.

Subjects are patients with malignant glioma histologically confirmed at diagnosis, who were treated previously with conventional external beam radiation (XRT) \& with or without chemo, \& have stable disease, recurrence/relapse at time of enrollment. Approximately 48 subjects will be enrolled.

Temozolomide has been well tolerated by both adults \& children with most common toxicity being mild myelosuppression. Other, less likely, potential toxicities include nausea \& vomiting, constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy, \& hepatotoxicity. Hypersensitivity reactions have not yet been noted with Temozolomide. As is case with many anti-cancer drugs, Temozolomide may be carcinogenic. Rats given Temozolomide have developed breast cancer. Significance of this finding for humans is not presently known.

Significant adverse events observed for SCH66336 have included vomiting, diarrhea, anorexia, headaches, reversible renal toxicities, \& hematological toxicities. SCH 66336, although not genotoxic, inhibits rapidly proliferating cells \& at high doses inhibits spermatogenesis in male rats. It is not clear that inhibition of spermatogenesis is reversible,\& patients should be advised of possibility of irreversible sterility.

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

Schering-Plough

Duke University

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Neoplasm Metastasis

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematinics

Herbal and Botanical

Liver Extracts

Cola

Starting dose of preoperative oral SCH 66336 100 mg twice daily for 7-14 days prior to exploratory laparotomy and/or resection of hepatic metastases with surgery between days 8-15.

Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization.

SCH 66336

Exploratory laparotomy and/or resection of hepatic metastases. Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization. Other patients undergo surgery on days 8-15.

conventional surgery

Steven A. Curley, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase I trial to compare the effectiveness of different doses of SCH 66336 before surgery in treating patients who have colorectal cancer that has metastasized to the liver.

OBJECTIVES: I. Determine the biologic activity and safety of preoperative SCH 66336 in patients with colorectal carcinoma metastatic to the liver.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four doses of preoperative SCH 66336 (no treatment, 100 mg, 200 mg, or 300 mg). Patients receive oral SCH 66336 twice daily for 7-14 days prior to exploratory laparotomy and/or resection of hepatic metastases. Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization. Other patients undergo surgery on days 8-15.

PROJECTED ACCRUAL: A total of 40 patients (10 per arm) will be accrued for this study within 10 months.

SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver

A Phase IB Study of Oral Administration of SCH 66336 Preoperatively in Patients With Colorectal Carcinoma Metastatic to the Liver Scheduled for Exploratory Laparotomy and/or Resection

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PH I Addition of Farnesyl Transferase Inhibitor to Temozolomide for Pts w Gr 3 & 4 Malignant Gliomas	NCT00612651	Gliosarcoma Glioblastoma Anaplastic Astr...	Temodar and SCH...	18 Years -	Duke University
SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver	NCT00005030	Colorectal Canc... Metastatic Canc...	SCH 66336 conventional su...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for sch 66336

Every month we try and update this database with for sch 66336 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sch 66336

Every month we try and update this database with for sch 66336 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sch 66336 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.