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
- Determine the maximum tolerated dose and dose-limiting toxicity of mistletoe lectin
(recombinant viscumin) in patients with advanced solid tumors who have failed standard
- Determine the pharmacokinetics of this regimen in these patients.
- Determine whether induction of antibodies against recombinant viscumin occurs in these
- 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
PROJECTED ACCRUAL: A minimum of 37 patients will be accrued for this study.
Primary Purpose: Treatment
Patrick Schoffski, MD, MPH
Hannover Medical School
United States: Federal Government