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Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma


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

Inclusion 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)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Steven Rosenzweig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000258166

NCT ID:

NCT00052325

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IV non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107