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

This study is currently recruiting patients.

Sponsors and Collaborators: Kimmel Cancer Center (KCC)
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Supplemental Treatment With Mistletoe in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving Palliative Chemotherapy

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other


Location and Contact Information


Pennsylvania
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Steven Rosenzweig, MD  215-503-0720 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005