Phase II Study of Supplemental Treatment With Mistletoe in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving Palliative Chemotherapy. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

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Alternate Title

Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCITJUH-01F.45
TJUH-2001-35, NCT00052325

Objectives

  1. 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.
  2. Determine the tolerability of this drug in these patients.
  3. Correlate immune function and quality of life in patients treated with this drug.

Entry 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

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)

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

Expected Enrollment

Not specified

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.

Trial Contact Information

Trial Lead Organizations

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Steven Rosenzweig, MD, Protocol chair
Ph: 215-503-0720; 800-533-3669

Registry Information

Official TitleIscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
Trial Start Date2002-10-01
Registered in ClinicalTrials.govNCT00052325
Date Submitted to PDQ2002-09-24
Information Last Verified2005-07-11
NCI Grant/Contract NumberCA56036, AT01020

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.