Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00066651
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced malignancy of 1 of the following types:
* Ovarian cancer
* All nonmucinous epithelial histologies are eligible
* Primary peritoneal cavity cancer
* Fallopian tube cancer
* Malignant mesothelioma
* No sarcomatous histology
* Pancreatic cancer
* Squamous cell cancer (SCC) of the lung
* SCC of the cervix
* SCC of the head and neck
* Recurrent unresectable disease, meeting 1 of the following criteria:
* Previously treated with definitive standard therapy
* Patient refused prior standard therapy
* Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry\* NOTE: \*Immunohistochemical evaluation not required for patients with pancreatic cancer
* Measurable or evaluable disease
* No clinically significant pericardial effusion
* No known CNS or spinal cord involvement by tumor
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 1,500/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
* Seropositive allowed if clinically asymptomatic
* except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria
Renal
* Creatinine no greater than ULN
* Calcium no greater than ULN
Cardiovascular
* No New York Heart Association class II-IV cardiovascular disease
Pulmonary
* Oxygen saturation at least 93% on room air
* DLCO at least 50% of predicted\*
* Total lung capacity and vital capacity at least 50% of predicted\*
* FEV\_1 at least 50% of predicted\* NOTE: \*For patients with pleural mesothelioma and as clinically indicated
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No infection requiring parenteral antibiotics
* No HIV infection
* Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75%
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 4 weeks since prior therapy and recovered
* No other concurrent antitumor therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00066651
Study Brief:
Protocol Section:
NCT00066651