NCT00006354

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	mistletoe extract

Timeline

• Start date: 2000-08-01
• Primary completion: 2003-03-01
• First posted: 2003-01-27
• Last updated: 2012-07-24

Locations

2 sites across 2 countries: France, Germany