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

NCT00747916 | Terminated Phase 4 Results

• 1 other identifier: 17-00027
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pleural Neoplasms

Keywords

Parietal pleura; Neoplasms; Pleural Surface; Pleural Neoplasms; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

CryoSpray Ablation (TM) System

EXPERIMENTAL

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

Device: CryoSpray Ablation (TM) System

Interventions

CryoSpray Ablation (TM) System DEVICE

Subjects will be treated with spray cryotherapy using the CryoSpray Ablation (TM) System at Day 0 using up to 3 cycles of 10-40 second sprays as the studied dosimetry and will cover the affected area, including the tumor and the parietal pleural surface. If disease exists bilaterally, only one side will be sprayed. Subjects will be assessed 2-5 days from the initial treatment (Day 0) to check for mucosal sloughing, to reassess tumor burden and for additional CSA therapy as needed.

Also known as: CSA (TM) System, CryoSpray Therapy, CSA, Cryotherapy, Cryospray

CryoSpray Ablation (TM) System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (1)

University of Texas Health Center at Tyler - Titus Regional Hospital

Tyler, Texas, 75702, United States

Location

Related Publications (18)

• 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.

  PMID: 16301023 BACKGROUND

• 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.

  PMID: 10385730 BACKGROUND

• Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3.

  PMID: 10734018 BACKGROUND

• Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54. doi: 10.1016/0016-5085(94)90123-6.

  PMID: 8076761 BACKGROUND

• Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.

  PMID: 8995932 BACKGROUND

• Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.

  PMID: 14629105 BACKGROUND

• Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34. doi: 10.1186/1477-7819-5-34.

  PMID: 17367523 BACKGROUND

• Field JK, Youngson JH. The Liverpool Lung Project: a molecular epidemiological study of early lung cancer detection. Eur Respir J. 2002 Aug;20(2):464-79. doi: 10.1183/09031936.02.00290202.

  PMID: 12212983 BACKGROUND

• Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.

  PMID: 10349923 BACKGROUND

• Dumot JA. Cryotherapy Ablation for Esophageal HGD or IMCA in High Risk, Non-Surgical Patients. DDW2007 Abstract submission. Cleveland Clinic Foundation (pending publication)

  BACKGROUND

• Greenwald BD. CryoSpray Ablation of Early Esophageal Cancer. DDW 2007 Abstract submission. University of Maryland Medical Center. (pending publication)

  BACKGROUND

• Johnston M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.

  BACKGROUND

• 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.

  BACKGROUND

• Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 2000.

  BACKGROUND

• 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.

  BACKGROUND

• Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pleural Neoplasms; Lung Neoplasms

Interventions

Drug Delivery Systems; Cryotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Gordon Downie
• Organization: Titus Regional Medical Center

downieg@trhta.net

903-572-9050

Study Officials

• Gordon Downie, M.D., Ph.D

  University of Texas Health Center at Tyler

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 8, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 16, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-06

Locations

US (1)