Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

Phase 1 Completed Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI) · collab

Treatment

Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in treating patients who have malignant primary glioma.

Timeline

Start: 2002-01-28
Primary completion: 2005-03-17
Completion: 2005-11-01

Publications

Results Prados MD, Yung WK, Wen PY, Junck L, Cloughesy T, Fink K, Chang S, Robins HI, Dancey J, Kuhn J. Phase-1 trial of gefitinib and temozolomide in patients with malignant glioma: a North American brain tumor consortium study. Cancer Chemother Pharmacol. 2008 May;61(6):1059-67. doi: 10.1007/s00280-007-0556-y. Epub 2007 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefitinib	Small molecule	250 mg	Oral
Subject	Gefitinib	Small molecule	500 mg	Oral
Subject	Gefitinib	Small molecule	1000 mg	Oral
Subject	Temozolomide	Small molecule	150 mg/m2	Oral
Subject	Temozolomide	Small molecule	200 mg/m2	Oral

Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

Summary

Timeline

Publications

Drugs

Indications