Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

June 17, 2013 updated by: National Center for Complementary and Integrative Health (NCCIH)

A Phase I Study Of The Effect Of Mistletoe Extract, A Complementary Medicine Botanical, On Pharmacokinetics, Pharmacodynamics And Safety Of Gemcitabine In Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Mistletoe may slow the growth of tumor cells and may be an effective treatment for solid tumors.

PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in treating patients who have advanced solid tumors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of gemcitabine and mistletoe in patients with advanced solid tumors.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the pharmacokinetic effects of gemcitabine with and without mistletoe in these patients.
  • Determine tumor response in patients treated with this regimen.
  • Determine the time to neutrophil count recovery in patients treated with this regimen.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and mistletoe subcutaneously daily starting on day 8 of course 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Patients receive escalating doses of gemcitabine and mistletoe in 2 stages.

  • Stage I: Cohorts of 3-6 patients receive escalating doses of mistletoe in combination with a constant dose of gemcitabine until the maximum tolerated dose (MTD) of mistletoe is determined.
  • Stage II: Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with the MTD of mistletoe as determined in stage I until the MTD of gemcitabine is determined.

In both stages, the MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 45-51 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

51

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic, recurrent, or unresectable locally advanced solid tumor, including one of the following:

    • Breast or colorectal cancer that has failed first-line chemotherapy
    • Non-small cell lung cancer
    • Pancreatic Cancer
  • No CNS metastases

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • No clinically significant hepatic dysfunction

Renal

  • Creatinine no greater than 2.5 mg/dL
  • No clinically significant renal dysfunction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • HIV negative
  • No clinically significant unrelated illness (e.g., serious infection or organ dysfunction) that would preclude study tolerance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior mistletoe

Chemotherapy

  • See Disease Characteristics
  • No prior gemcitabine
  • More than 30 days since prior chemotherapy and recovered

Endocrine therapy

  • More than 30 days since prior glucocorticosteroid therapy

Radiotherapy

  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • At least 30 days since prior investigational agents
  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Patrick J. Mansky, MD, National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000258130
  • NCCAM-02-AT-260
  • NCI-02-AT-0260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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