Immunotoxin Therapy in Treating Patients With Advanced Cancer

National Cancer Institute (NCI)

Overview

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for advanced cancer. PURPOSE: Phase I trial to study the effectiveness of immunotoxins in treating patients who have advanced cancer.

OBJECTIVES: Primary * Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in patients with advanced malignancies that express mesothelin. Secondary * Determine the response in patients treated with this drug. * Determine the plasma pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive SS1(dsFv)-PE38 immunotoxin IV continuously on days 1-10. Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Cervical Cancer Fallopian Tube Cancer Head and Neck Cancer Lung Cancer Malignant Mesothelioma Ovarian Cancer Pancreatic Cancer Primary Peritoneal Cavity Cancer

Interventions

SS1(dsFv)-PE38 immunotoxinBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed malignancy, including one of the following: * Malignant mesothelioma * Ovarian epithelial carcinoma (mucinous or nonmucinous), including primary peritoneal or fallopian tube carcinoma * Tumors that may have originated in the bowel (e.g., appendiceal carcinoma) and involve the ovary * Ovarian cancers of other histology are eligible provided they express mesothelin * Pancreatic cancer * Squamous cell lung cancer * Squamous cell cancer of the head and neck * Squamous cell cancer of the cervix * Recurrent unresectable disease after prior standard anticancer therapy that was expected to prolong survival and improve quality of life OR unwilling to receive standard anticancer therapy * At least 30% of initial or recurrent tumor cells positive (at least 1+) for mesothelin by immunohistochemistry * Measurable or evaluable disease * No known CNS or spinal cord involvement * No clinically significant pericardial effusion PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * Albumin at least 3.0 g/dL * Hepatitis B and C negative Renal: * Creatinine no greater than ULN OR * Creatinine no greater than 2.0 mg/dL if creatinine clearance at least 50 mL/min * Calcium no greater than ULN Cardiovascular: * No New York Heart Association class II-IV heart disease Pulmonary: * Oxygen saturation (SO\_2) more than 92% on room air Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No detectable antibody to SS1(dsFv)-PE38 * No infection requiring parenteral antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior hematopoietic growth factor therapy Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 4 weeks since any prior antitumor therapy and recovered * No other concurrent antitumor therapy

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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