NCT00052325

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

July 1, 2005

First QC Date

January 24, 2003

Last Update Submit

December 17, 2013

Conditions

Lung Cancer

Keywords

stage IV non-small cell lung cancerstage IIIB non-small cell lung cancer

Interventions

mistletoe extractDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Steven Rosenzweig, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

October 1, 2002

Last Updated

December 18, 2013

Record last verified: 2005-07

Locations

US(1)