Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")

Phase 4

Terminated

Brief Summary: The purpose of this study is to evaluate the safety, efficacy, and side effects of the CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal pleural surface.

Detailed Description: The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci.

Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary, dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if dosimetry will need to be increased to enhance effectiveness. The PI may increase dosimetry by 1 cycle after each subject is treated and observed as a conservative approach to efficacy determination. If disease exists bilaterally, only one side will be sprayed.

Recruitment & Eligibility

Inclusion Criteria

18 years of age
Deemed a candidate for cryotherapy based on physician physical or medical history review
Deemed operable based on institutional criteria
Able to sign informed consent
Documented lung or other visceral cancer with pleural involvement.
WBC > 4,000/mm3, platelets >100,000mm3
Physically well enough to undergo moderate sedation and pleuroscopy
Female patients must be HCG negative
There should be direct evidence of disease progression despite treatment in previously treated patients

Exclusion Criteria

Pregnant or nursing
Planning to sire a child while enrolled in the study
Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
Refusal or inability to give consent.
Concurrent chemotherapy.
Medical contraindication or potential problem that would preclude study participation
Concurrent participation in other experimental studies
Uncontrolled coagulopathy or bleeding diathesis
Serious medical illness, including:
Uncontrolled congestive heart failure
Uncontrolled angina
Myocardial infarction
Cerebrovascular accident within 6 months prior to study entry

Arm && Interventions

Group	Intervention	Description
CryoSpray Ablation (TM) System	CryoSpray Ablation (TM) System	subjects will receive cryotherapy using the CryoSpray Ablation (TM) System DOSE: up to 3 cycles of 10-40 second sprays

Primary Outcome Measures

Name	Time	Method
To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.	1 year

Secondary Outcome Measures

Name	Time	Method
To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent.	1 year