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

Sponsors and Collaborators:	Kimmel Cancer Center (KCC) National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052325

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: mistletoe extract	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Viscumin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 2002

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052325

Locations

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

Sponsors and Collaborators

Kimmel Cancer Center (KCC)

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven Rosenzweig, MD

Kimmel Cancer Center (KCC)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000258166, TJUH-01F.45, TJUH-2001-35
Study First Received:	January 24, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00052325
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009