NCT00049608

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 19, 2013

Status Verified

April 1, 2007

First QC Date

November 12, 2002

Last Update Submit

June 17, 2013

Conditions

Breast CancerColorectal CancerLung CancerPancreatic Cancer

Keywords

male breast cancerrecurrent breast cancerrecurrent colon cancerrecurrent non-small cell lung cancerrecurrent pancreatic cancerrecurrent rectal cancerstage III colon cancerstage III pancreatic cancerstage III rectal cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerstage IV colon cancerstage IV non-small cell lung cancerstage IV rectal cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV pancreatic cancer

Interventions

mistletoe extractDIETARY_SUPPLEMENT
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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.

    PMID: 24285980RESULT

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsLung NeoplasmsPancreatic NeoplasmsBreast Neoplasms, MaleColonic NeoplasmsCarcinoma, Non-Small-Cell LungRectal Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Patrick J. Mansky, MD

    National Center for Complementary and Integrative Health (NCCIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Study Completion

August 1, 2011

Last Updated

June 19, 2013

Record last verified: 2007-04

Locations

US(1)