Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous 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.
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: mistletoe extract
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||August 2000|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
- 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.
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Study Chair:||Patrick Schoffski, MD, MPH||Hannover Medical School|