Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00006981


Primary Contact:

Study Chair
Robert Kreitman, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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