A Phase 1 interventional study of mistletoe extract in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-24.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 41 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
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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:
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC