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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT00066404
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following histologically or cytologically confirmed diagnoses:
* Malignant pleural mesothelioma
* Metastatic malignancy to the pleural space
* Originating from 1 of the following sites:
* Lung
* Breast
* Gastrointestinal organs
* Genitourinary organs
* Malignant melanoma
* Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy
* Measurable or evaluable disease
* Pleural space involved with tumor accessible for pleural catheter insertion
* No malignant pleural effusions secondary to lymphoma or sarcoma
* No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis
* No known brain metastases
* Previously treated brain metastases with no evidence of active growth are allowed
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hematocrit at least 30% (transfusion allowed)
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT and AST no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 1.5 times ULN
* PT and PTT no greater than 1.5 times normal
* No end-stage liver disease
* No chronic active hepatitis B (hepatitis B surface antigen negative)
Renal
* Creatinine no greater than 2.0 mg/dL
* No end-stage renal disease
Cardiovascular
* No unstable angina
Pulmonary
* FEV\_1 greater than 50% of predicted (post-pleural drainage)
* No severe oxygen-dependent chronic obstructive pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No documented immunodeficiency
* No other malignancy within the past 5 years except nonmelanoma skin cancer or successfully treated localized malignancy of the bladder or prostate gland with no evidence of active disease
* No other life-threatening illness
* No known hypersensitivity to any component of study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior biologic therapy
* No prior bone marrow transplantation, including stem cells
* No immunological drugs during and for at least 2 months after study therapy
Chemotherapy
* See Disease Characteristics
* No chemotherapy during and for at least 2 months after study therapy
Endocrine therapy
* See Disease Characteristics
* Concurrent hormonal therapy allowed if maintained at dose received prior to study entry
* No concurrent steroids
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No radiotherapy during and for at least 2 months after study therapy
Surgery
* At least 2 weeks since prior surgery
Other
* More than 4 weeks since prior cytotoxic agents
* No concurrent immunosuppressives or medication that can directly or indirectly suppress the immune system
* No other concurrent experimental therapies for pleural cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00066404
Study Brief:
Protocol Section:
NCT00066404