Trial record 2 of 2 for:    mistletoe | NCCAM

Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

This study has been terminated.
(Principal investigator [PI] has left institution.)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049608
First received: November 12, 2002
Last updated: June 17, 2013
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Colorectal Cancer
Lung Cancer
Pancreatic Cancer
Dietary Supplement: mistletoe extract
Drug: gemcitabine hydrochloride
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 51
Study Start Date: July 2002
Study Completion Date: August 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049608

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Patrick J. Mansky, MD National Center for Complementary and Alternative Medicine (NCCAM)
  More Information

Additional Information:
Publications:
Mansky PJ, Wallerstedt DB, Sannes T, et al.: NCCAM/NCI phase I study of mistletoe extract and gemcitabine in patients with advanced solid tumors. [Abstract] J Clin Oncol 28 (Suppl 15): A-2559, 2010.

ClinicalTrials.gov Identifier: NCT00049608     History of Changes
Obsolete Identifiers: NCT00044161
Other Study ID Numbers: CDR0000258130, NCCAM-02-AT-260, NCI-02-AT-0260
Study First Received: November 12, 2002
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
male breast cancer
recurrent breast cancer
recurrent colon cancer
recurrent non-small cell lung cancer
recurrent pancreatic cancer
recurrent rectal cancer
stage III colon cancer
stage III pancreatic cancer
stage III rectal cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
stage IV colon cancer
stage IV non-small cell lung cancer
stage IV rectal cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014