Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Center for Complementary and Integrative Health (NCCIH)
With
OBJECTIVES: * 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 these patients. * 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 is determined. * 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 dose-limiting toxicity. PROJECTED ACCRUAL: A total of 45-51 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
