Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052325
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2003-01-24
Brief Title:
Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
Status:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Mistletoe may help the body build an immune response and may improve quality of life to help patients live more comfortably
PURPOSE This phase II trial is studying mistletoe to see how well it works in treating patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying mistletoe to see how well it works in treating patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine whether supplemental treatment with mistletoe increases immune function as determined by total lymphocyte count eosinophil count and lymphocyte subset analysis in patients with stage IIIB or IV non-small cell lung cancer receiving palliative chemotherapy
Determine the tolerability of this drug in these patients
Correlate immune function and quality of life in patients treated with this drug
OUTLINE This is an open-label non-randomized multicenter study
Patients receive mistletoe subcutaneously three times a week for 15 weeks
Dose of mistletoe is increased at weeks 2 and 3 and then every 3 weeks until a maximum response is seen dose-limiting toxicity occurs or the study ends
Quality of life is assessed at baseline and at weeks 3 6 9 12 and 15
PROJECTED ACCRUAL Not specified
Determine whether supplemental treatment with mistletoe increases immune function as determined by total lymphocyte count eosinophil count and lymphocyte subset analysis in patients with stage IIIB or IV non-small cell lung cancer receiving palliative chemotherapy
Determine the tolerability of this drug in these patients
Correlate immune function and quality of life in patients treated with this drug
OUTLINE This is an open-label non-randomized multicenter study
Patients receive mistletoe subcutaneously three times a week for 15 weeks
Dose of mistletoe is increased at weeks 2 and 3 and then every 3 weeks until a maximum response is seen dose-limiting toxicity occurs or the study ends
Quality of life is assessed at baseline and at weeks 3 6 9 12 and 15
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| TJUH-2001-35 | None | None | None |
| TJUH-01F45 | None | None | None |