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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

mistletoe extract

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00052325

First Posted

January 24, 2003

Last Updated

December 17, 2013

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00052325

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2005

Overall Recruitment Status

Unknown status

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

mistletoe extract

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Rosenzweig, MD

Organizational Affiliation

Sidney Kimmel Cancer Center at Thomas Jefferson University

Official's Role

Study Chair

Facility Information:

Facility Name

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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