This trial is active, not recruiting.

Condition lung cancer
Treatment mistletoe extract
Phase phase 2
Sponsor Kimmel Cancer Center (KCC)
Collaborator National Cancer Institute (NCI)
Start date October 2002
Trial identifier NCT00052325, CDR0000258166, TJUH-01F.45, TJUH-2001-35


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).