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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00006354
First received: October 4, 2000
Last updated: July 23, 2012
Last verified: July 2012

October 4, 2000
July 23, 2012
August 2000
March 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00006354 on ClinicalTrials.gov Archive Site
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Not Provided
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Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
Phase I Clinical Trial of Recombinant Viscumin (rViscumin, rMistletoe Lectin, rML) Administered Twice Weekly By The Intravenous Route In Patients With Solid Tumors After Failure of Standard Therapy

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: mistletoe extract
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
Not Provided
March 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00006354
EORTC-16002, EORTC-16002
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Patrick Schoffski, MD, MPH Hannover Medical School
European Organisation for Research and Treatment of Cancer - EORTC
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP