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CompletedNCT00006354Updated Jul 24, 2012

Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy

A Phase 1 interventional study of mistletoe extract in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-24.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
41
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Mistletoe lectin may slow the growth of cancer cells and be an effective treatment for solid tumors.

PURPOSE: Phase I trial to study the effectiveness of mistletoe lectin in treating patients who have advanced solid tumors that have not responded to previous therapy.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of mistletoe lectin (recombinant viscumin) in patients with advanced solid tumors who have failed standard therapy.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine whether induction of antibodies against recombinant viscumin occurs in these patients.
  • Determine whether immunological stimulation at the RNA level of immune cells occurs in patients treated with this regimen.
  • Determine whether modification of endothelial parameters occurs in patients treated with this regimen.
  • Determine the objective response rates in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive mistletoe lectin (recombinant viscumin) IV over 1 hour twice weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-3 patients receive escalating doses of recombinant viscumin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience dose-limiting toxicity during the first course. Additional patients are treated at the MTD.

Patients are followed every 3 months until disease progression or initiation of another therapy.

PROJECTED ACCRUAL: A minimum of 37 patients will be accrued for this study.

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Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 41 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven progressive advanced solid tumor that is not amenable to standard therapy (i.e., resistant to standard therapy or for which no standard therapy exists)
  • No clinically symptomatic CNS involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm\^3
  • Neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase less than 2.5 times ULN (5 times ULN if liver metastases present)

Renal:

  • Creatinine less than 1.4 mg/dL

Cardiovascular:

  • No ECG abnormalities of clinical relevance

Other:

  • No severe or unstable systemic disease or infection
  • No circumstances (e.g., alcoholism or substance abuse) that would preclude study participation
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunostimulating substances, biologic response modifiers, or colony-stimulating factors
  • No concurrent immunostimulating substances, colony-stimulating factors (except in life-threatening situations), biologic response modifiers, or monoclonal antibodies

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • At least 4 weeks since prior systemic steroids
  • No concurrent systemic steroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No prior mistletoe preparations
  • At least 4 weeks since prior investigational treatment
  • No other concurrent anticancer agents
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Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
41 participants (actual)

Interventions

  • Dietary supplementmistletoe extract
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Study locations

2 sites
  • Centre Regional Rene Gauducheau
    Nantes-Saint Herblain, 44805, France
  • Medizinische Hochschule Hannover
    Hannover, D-30625, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00006354
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Aug 2000
Primary completion
Mar 2003
Last update
Jul 24, 2012

Study contacts

Patrick Schoffski, MD, MPH
study chair · Hannover Medical School
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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