RATIONALE: Mistletoe may help the body build an immune response and may improve quality of life to help patients live more comfortably.

PURPOSE: Phase II trial to study the effectiveness of mistletoe in treating patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer	Drug: mistletoe  Procedure: biological response modifier therapy  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: herbal medicine / botanical therapy  Procedure: non-specific immune-modulator therapy	Phase II

Further Study Details: 

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 Loranthaceae

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)

Pennsylvania
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting

Study chairs or principal investigators

Steven Rosenzweig, MD,  Study Chair,  Kimmel Cancer Center (KCC)   

Study ID Numbers:  CDR0000258166; TJUH-01F.45; TJUH-2001-35; NCT00052325
Record last reviewed:  July 2004
Last Updated:  March 10, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052325
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08