Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors

NCT00006477 | Completed Phase 1

• 1 other identifier: EORTC-13001
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

mistletoe extract DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (2)

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (1)

• Bergmann 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 RESULT

Study Officials

• Steinar Aamdal, MD, PhD

  Norwegian Radium Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Primary Completion: June 1, 2004
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

DE (1); NO (1)