A Phase I Study Of The Effect Of Mistletoe Extract, A Complementary Medicine Botanical, On Pharmacokinetics, Pharmacodynamics And Safety Of Gemcitabine In Patients With Advanced Solid Tumors
- Determine the maximum tolerated dose of gemcitabine and mistletoe in patients with
advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetic effects of gemcitabine with and without mistletoe in
- Determine tumor response in patients treated with this regimen.
- Determine the time to neutrophil count recovery in patients treated with this regimen.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and mistletoe subcutaneously
daily starting on day 8 of course 1. Treatment repeats every 21 days for at least 3 courses
in the absence of disease progression or unacceptable toxicity.
Patients receive escalating doses of gemcitabine and mistletoe in 2 stages.
- Stage I: Cohorts of 3-6 patients receive escalating doses of mistletoe in combination
with a constant dose of gemcitabine until the maximum tolerated dose (MTD) of mistletoe
- Stage II: Cohorts of 3-6 patients receive escalating doses of gemcitabine in
combination with the MTD of mistletoe as determined in stage I until the MTD of
gemcitabine is determined.
In both stages, the MTD is defined as the dose preceding that at which 2 patients experience
PROJECTED ACCRUAL: A total of 45-51 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Patrick J. Mansky, MD
National Center for Complementary and Alternative Medicine (NCCAM)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|