Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-16002 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mistletoe extract | Dietary Supplement |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick Schoffski, MD, MPH | Hannover Medical School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Regional Rene Gauducheau | Nantes-Saint Herblain | 44805 | France | |||
| Medizinische Hochschule Hannover |
Not provided
Not provided
Not provided
Not provided
Not provided
| Hanover |
| D-30625 |
| Germany |