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

Primary Purpose

Cancer, Pleural Neoplasms

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CryoSpray Ablation (TM) System

About this trial

This is an interventional treatment trial for Cancer focused on measuring Parietal pleura, Neoplasms, Pleural Surface, Pleural Neoplasms, Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Texas Health Center at Tyler - Titus Regional Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CryoSpray Ablation (TM) System

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00747916

First Posted

September 4, 2008

Last Updated

June 23, 2015

Sponsor

CSA Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00747916

Brief Title

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

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Business Reasons

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSA Medical, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Pleural Neoplasms

Keywords

Parietal pleura, Neoplasms, Pleural Surface, Pleural Neoplasms, Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CryoSpray Ablation (TM) System

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CryoSpray Ablation (TM) System

Other Intervention Name(s)

CSA (TM) System, CryoSpray Therapy, CSA, Cryotherapy, Cryospray

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gordon Downie, M.D., Ph.D

Organizational Affiliation

University of Texas Health Center at Tyler

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Center at Tyler - Titus Regional Hospital

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16301023

Citation

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Results Reference

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PubMed Identifier

10385730

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.

Results Reference

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PubMed Identifier

10734018

Citation

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.

Results Reference

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PubMed Identifier

8076761

Citation

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.

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PubMed Identifier

8995932

Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

17367523

Citation

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.

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PubMed Identifier

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Citation

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.

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Citation

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.

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

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

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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.

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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.

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

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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.

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

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