Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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.
Interventions
DIETARY_SUPPLEMENTmistletoe extract
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
France, Germany
Outcome results
None listed