Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy

NCT ID: NCT00006354

Last Updated: 2012-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31

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 advanced solid tumors that have not responded to previous therapy.

Detailed Description

OBJECTIVES:

• 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.
• Determine the pharmacokinetics of this regimen in these patients.
• Determine whether induction of antibodies against recombinant viscumin occurs in these patients.
• Determine whether immunological stimulation at the RNA level of immune cells occurs in patients treated with this regimen.
• Determine whether modification of endothelial parameters occurs in patients treated with this regimen.
• Determine the objective response rates in patients treated with this regimen.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

mistletoe extract

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion 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

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 2.5 times ULN (5 times ULN if liver metastases present)
• Alkaline phosphatase less than 2.5 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 participation
• 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, biologic response modifiers, or colony-stimulating factors
• No concurrent immunostimulating substances, colony-stimulating factors (except in life-threatening situations), biologic response modifiers, or monoclonal antibodies

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy
• At least 4 weeks since prior systemic steroids
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Schoffski, MD, MPH

Role: STUDY_CHAIR

Hannover Medical School

Locations

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, , France

Medizinische Hochschule Hannover

Hanover, , Germany

Countries

France; Germany

Other Identifiers

EORTC-16002

Identifier Type: -

Identifier Source: secondary_id

EORTC-16002

Identifier Type: -

Identifier Source: org_study_id