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||Phase 1|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006354
|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|