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Sponsors and Collaborators: |
Kimmel Cancer Center (KCC) National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052325 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: mistletoe extract |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma |
Study Start Date: | October 2002 |
OBJECTIVES:
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stage IIIB or IV non-small cell lung cancer
Planning to receive standard chemotherapy with either carboplatin plus paclitaxel or cisplatin plus gemcitabine
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Pennsylvania | |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Chair: | Steven Rosenzweig, MD | Kimmel Cancer Center (KCC) |
Study ID Numbers: | CDR0000258166, TJUH-01F.45, TJUH-2001-35 |
Study First Received: | January 24, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00052325 |
Health Authority: | United States: Federal Government |
stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |