Phase I Clinical Trial of Recombinant Viscumin (rVISCUMIN, rMISTLETOE LECTIN, rML) Administered Twice Weekly by the Subcutanous 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 optimal biologically active dose of mistletoe lectin based on analysis of
specific biological surrogate markers, including plasma cytokine levels and peripheral
counts of activated immune cells and immunological stimulation at the RNA level of the
- Determine the pharmacokinetics of this regimen in these patients.
- Determine whether induction of antibodies against mistletoe lectin occurs in these
- 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, multicenter study.
Patients receive mistletoe lectin (recombinant viscumin) subcutaneously twice weekly.
Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of mistletoe lectin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the
highest dose level immediately preceding the MTD.
Patients are followed every 3 months until disease progression or initiation of another
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Primary Purpose: Treatment
Steinar Aamdal, MD, PhD
Norwegian Radium Hospital
United States: Federal Government