Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Unknown; Phase 2

Conditions: Lung Cancer

Treatments: Dietary Supplement: mistletoe extract

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00052325

CDR0000258166

TJUH-01F.45

TJUH-2001-35

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)