Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 18 and over | NCI | TJUH-01F.45 TJUH-2001-35, NCT00052325 |
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.
Entry 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
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)
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
Expected Enrollment
Not specified
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.
Trial Lead Organizations
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 | | | |
| Steven Rosenzweig, MD, Protocol chair | |
| |
| |||
| Registry Information | ||
| ||
| Official Title | Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma | |
| ||
| Trial Start Date | 2002-10-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00052325 | |
| ||
| Date Submitted to PDQ | 2002-09-24 | |
| ||
| Information Last Verified | 2005-07-11 | |
| ||
| NCI Grant/Contract Number | CA56036, AT01020 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Back to Top
