mistletoe lectin in treating patients with advanced solid tumors that have not responded to previous therapy

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility 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

Keywords: unspecified adult solid tumor, protocol specific