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A Pilot Study of the Safety, Efficacy, and Side Effects of Interventional Cryotherapy for the Eradication of Disease in the Pleural Space ("ICE PLS")


Phase 4
18 Years
N/A
Not Enrolling
Both
Primary Malignancy With Metastasis to the Parietal Pleura, Pleural Surface Neoplasms

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Trial Information

A Pilot Study of the Safety, Efficacy, and Side Effects of Interventional Cryotherapy for the Eradication of Disease in the Pleural Space ("ICE PLS")


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Gordon Downie, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Health Center at Tyler

Authority:

United States: Institutional Review Board

Study ID:

17-00027

NCT ID:

NCT00747916

Start Date:

August 2008

Completion Date:

August 2011

Related Keywords:

  • Primary Malignancy With Metastasis to the Parietal Pleura
  • Pleural Surface Neoplasms
  • Parietal pleura
  • Neoplasms
  • Pleural Surface
  • Pleural Neoplasms
  • Lung Cancer
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

University of Texas Health Center at Tyler - Titus Regional Hospital Tyler, Texas  75702