Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
18 Years
N/A
Both
Lung Cancer
Trial Information
Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
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
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Stage IIIB or IV non-small cell lung cancer
- Newly diagnosed disease
- Planning to receive standard chemotherapy with either carboplatin plus paclitaxel or
cisplatin plus gemcitabine
- Refused or ineligible to participate in experimental chemotherapy clinical
trials
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- No AIDS
- Able to self-report quality of life
- No known allergy to Viscum album Linnaeus
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent mistletoe products
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent steroid or adrenocorticotropic hormone therapy
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent participation in other clinical trials
- No concurrent mushroom glucan or proteoglycan extracts
- No concurrent thymus extract
- No concurrent non-oncologic immunosuppressive therapy (e.g., therapy for rheumatoid
arthritis or after organ transplantation)
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Steven Rosenzweig, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kimmel Cancer Center (KCC)
Authority:
United States: Federal Government
Study ID:
CDR0000258166
NCT ID:
NCT00052325
Start Date:
October 2002
Completion Date:
Related Keywords:
- Lung Cancer
- stage IV non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
