Clinical trial NCT00747916: Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")
Official title: A Pilot Study of the Safety, Efficacy, and Side Effects of Interventional Cryotherapy for the Eradication of Disease in the Pleural Space ("ICE PLS")
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cancer
Pleural Neoplasms
Keywords: Parietal pleura
Neoplasms
Pleural Surface
Pleural Neoplasms
Lung Cancer
Lead sponsor: CSA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Tyler
country: United States
facility: University of Texas Health Center at Tyler - Titus Regional Hospital
state: Texas
Study officials:
affiliation: University of Texas Health Center at Tyler
name: Gordon Downie, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008.
citation: Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4.
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citation: Dumot JA. Cryotherapy Ablation for Esophageal HGD or IMCA in High Risk, Non-Surgical Patients. DDW2007 Abstract submission. Cleveland Clinic Foundation (pending publication)
citation: Greenwald BD. CryoSpray Ablation of Early Esophageal Cancer. DDW 2007 Abstract submission. University of Maryland Medical Center. (pending publication)
citation: Johnston M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.
citation: Johnston MH, Horwhat JD, Haluska, Moses FM. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model (Abstract). Gastrointestinal Endoscopy 51: AB98, 3462, 2000.
citation: Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 2000.
citation: Eastone JA, Horwhat D, Haluska O, Mathews J, Johnston M. Cryoablation of swine esophageal mucosa: A direct comparison to argon plasma coagulation (APC) and multipolar electrocoagulation (MPEC) [Abstract] Gastrointestinal Endoscopy 53: A3448, 2001.
citation: Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.
citation: Johnston MH, Cash BD, Horwhat JD, Johnston LR, Dykes CA, Mays HS. Cryoablation of Barrett's Esophagus (BE) [Abstract]. Gastroenterology 130 (4, Suppl.2): A640, 2006.
citation: Johnston MH, Cash BD, Dykes CA, Mays HS, Johnston LR. Cryoablation of dysplasia in Barrett's Esophagus (BE) and early stage esophageal cancer [Abstract]. Gastrointestinal Endoscopy 63 (5): April, 2006.