Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	Other	EORTC-13001 NCT00006477

Objectives

1. 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.
2. Determine the optimal biologically active dose of mistletoe lectin based on analysis of specific biological surrogate markers, including plasma cytokine levels and peripheral counts of activated immune cells and immunological stimulation at the RNA level of the immune cells.
3. Determine the pharmacokinetics of this regimen in these patients.
4. Determine whether induction of antibodies against mistletoe lectin occurs in these patients.
5. Determine whether modification of endothelial parameters occurs in patients treated with this regimen.
6. Determine the objective response rates in patients treated with this regimen.

Entry Criteria

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A maximum of 25 patients will be accrued for this study.

Outline

This is a dose-escalation, multicenter study.

Patients receive mistletoe lectin (recombinant viscumin) subcutaneously twice weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of mistletoe lectin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the highest dose level immediately preceding the MTD.

Patients are followed every 3 months until disease progression or initiation of another therapy.

Bergmann L, Aamdal S, Marreaud S, et al.: 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 44 (12): 1657-62, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Steinar Aamdal, MD, PhD, Study coordinator		Ph: 47-22-93-4000 Email: steinar.aamdal@medisin.uio.no

Registry Information
Official Title		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
Trial Start Date		2000-09-01
Registered in ClinicalTrials.gov		NCT00006477
Date Submitted to PDQ		2000-09-26
Information Last Verified		2000-12-21

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