Clinical trial · Interventional
Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
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
NCT00006477CI-TRIAL-00007470completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 refractory advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mistletoe extract | Dietary Supplement | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven progressive advanced solid tumor that is not amenable to standard therapy (i.e., resistant to standard therapy or for which no standard therapy exists) * No clinically symptomatic CNS involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT less than 2 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase less than 2 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine less than 1.4 mg/dL Cardiovascular: * No ECG abnormalities of clinical relevance Other: * No severe or unstable systemic disease or infection * No circumstances (e.g., alcoholism or substance abuse) that would preclude study * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunostimulating substances (e.g., biologic response modifiers or colony-stimulating factors) * No concurrent immunostimulating substances (e.g., biologic response modifiers or colony-stimulating factors (except in life-threatening situations)) Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * At least 4 weeks since prior systemic steroids * At least 4 weeks since prior hormonal therapy * No concurrent systemic steroids Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * No prior mistletoe preparations * At least 4 weeks since prior investigational treatment * No other concurrent anticancer agents * No other concurrent investigational therapy
References
Publications (1)
- RESULTBergmann L, Aamdal S, Marreaud S, Lacombe D, Herold M, Yamaguchi T, Wilhelm-Ogunbiyi K, Lentzen H, Zwierzina H; European Organisation for Research and Treatment of Cancer. Phase I trial of r viscumin (INN: aviscumine) given subcutaneously in patients with advanced cancer: a study of the European Organisation for Research and Treatment of Cancer (EORTC protocol number 13001). Eur J Cancer. 2008 Aug;44(12):1657-62. doi: 10.1016/j.ejca.2008.05.005. Epub 2008 Jul 2. PMID 18602257