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A Phase I Study of Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced Solid Malignancies (NCT00003708)

National Cancer Institute (NCI)
Cancer Therapy and Research Center, Texas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors.
  • Drug: temozolomide
    Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.
    • Temodar
    • Temodal
    • Temcad
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting toxicity of temozolomide in patients with advanced solid malignancies. II. Characterize the single- and multiple-dose pharmacokinetics of temozolomide following oral administration in these patients. III. Determine antitumor activity of temozolomide in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

2 locations

United States (2)
  • Brooke Army Medical Center
    Fort Sam Houston, Texas, United States, 78234
  • San Antonio Cancer Institute
    San Antonio, Texas, United States, 78229
Status:
completed
Type:
Interventional
Phase:
Start:
30 June, 1998
Updated:
06 August, 2012
Participants:
32
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