Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049608
Status:
TERMINATED
Last Update Posted:
2013-06-19
First Post:
2002-11-12
Brief Title:
Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal investigator PI has left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die Mistletoe may slow the growth of tumor cells and may be an effective treatment for solid tumors
PURPOSE Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in treating patients who have advanced solid tumors
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-AT-0260 | None | None | None |
| NCCAM-02-AT-260 | None | None | None |