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

Lung Cancer Clinical Trial

Official title:

Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00052325
• Other study ID #: CDR0000258166
• Secondary ID: TJUH-01F.45TJUH-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 24, 2003
• Last updated: December 17, 2013
• Start date: October 2002

Study information

• Verified date: July 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Dietary Supplement:
• mistletoe extract

Locations

Country	Name	City	State
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Kimmel Cancer Center (KCC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,