A Phase-I Study Of Cyclical Oral Administration Of Temozolomide In Combination With PEG12000-Interferon Alfa-2B In Patients With Refractory And/Or Advanced Solid Tumors
OBJECTIVES:
- Determine the safety and tolerability of temozolomide and PEG-interferon alfa-2b in
patients with advanced refractory solid tumors or chemotherapy-naive advanced cancer.
- Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of this regimen
in this patient population.
- Determine the pharmacokinetics of PEG-interferon alfa-2b at the MTD when administered
with temozolomide in this patient population.
- Determine the anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral temozolomide on days 1-7 and 15-21 and PEG-interferon alfa-2b
subcutaneously on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 1-9 patients receive escalating doses of temozolomide and PEG-interferon alfa-2b
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Lionel D. Lewis, MD
Study Chair
Norris Cotton Cancer Center
United States: Institutional Review Board
CDR0000068523
NCT00014261
October 2000
Name | Location |
---|---|
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |