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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052325
First received: January 24, 2003
Last updated: December 17, 2013
Last verified: July 2005
  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
Dietary Supplement: mistletoe extract
Phase 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)
Investigators
Study Chair: Steven Rosenzweig, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00052325     History of Changes
Other Study ID Numbers: CDR0000258166, TJUH-01F.45, TJUH-2001-35
Study First Received: January 24, 2003
Last Updated: December 17, 2013
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014