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Breast CancerPhase 1NCT00049608

Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing mistletoe extract and gemcitabine hydrochloride in people with Breast Cancer and Colorectal Cancer, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Colorectal Cancer, Lung Cancer
What is being tested?
mistletoe extract and gemcitabine hydrochloride
How many people
51 participants
Where
1 siteUnited States
Study dates
Jul 2002to Aug 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
mistletoe extract, gemcitabine hydrochloride
Keywords
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
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Male, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2002
  3. Study completionAug 2011

Why it stopped: Principal investigator \[PI\] has left institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049608
Sponsor's protocol ID
CDR0000258130
Other IDs
NCCAM-02-AT-260, NCI-02-AT-0260
Status last verified
Apr 2007
First submitted
12 Nov 2002
Last updated
19 Jun 2013
Results posted
No

Publications

  • Mansky PJ, Wallerstedt DB, Sannes TS, Stagl J, Johnson LL, Blackman MR, Grem JL, Swain SM, Monahan BP. NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors. Evid Based Complement Alternat Med. 2013;2013:964592. doi: 10.1155/2013/964592. Epub 2013 Oct 27.

    PubMed 24285980

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mistletoe extract and gemcitabine hydrochloride in people with Breast Cancer and Colorectal Cancer, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Principal investigator \[PI\] has left institution.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049608, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.

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