Interstitial Fluid Pressure (IFP) Pilot Study in Melanoma Patients

February 20, 2012 updated by: M.D. Anderson Cancer Center

A Pilot Study Assessing the Feasibility and Safety of Measuring Interstitial Fluid Pressure (IFP) in Patients With Advanced Malignant Melanoma Before Starting Systemic Treatment

The goal of this clinical research study is to learn about the side effects of measuring the tumor pressure in patients who have advanced melanoma and have not received chemotherapy. Researchers also want to learn if patients with a lower tumor pressure may respond better to chemotherapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Tumor Pressure Testing:

If you are found to be eligible to take part in this study, the pressure in up to three tumors will be measured. Medical photography will also be used for documentation if needed.

This will be done in the melanoma outpatient clinic. You will be asked to lie down and the skin over the lesion will be cleaned with betadine (iodine) or a different cleaning agent if you are allergic to iodine. The skin over the lesion will then be numbed with anesthetic. A topical anesthetic is a local anesthetic that is used to numb the surface of a body part. Thirty minutes before the IFP measurement, an EMLA patch (Lidocaine 2.5% and Prilocaine 2.5%) will be applied on the surface of study. Your treating doctor may prescribe a pain drug to help with any discomfort the measurement may cause.

For the tumor measurement, the tip of a needle will be inserted in a skin lesion (similar to a biopsy needle). The needle is connected to a machine that reads the pressure inside the tumor. The measurement itself will take a few seconds. The whole process, including cleaning and numbing the lesion, will take about 3-4 minutes.

You will stay in the clinic and be monitored for side effects for about 1 hour following the tumor measurement.

At 3 days after the measurement, you will be asked if you have experienced any side effects. If you are not coming to the clinic, you will be called.

Length of Study:

You will be off study after you have completed two cycles of chemotherapy and the second set of tumor measurements are done.

Follow-Up:

After the 2 cycles of chemotherapy, you will be checked for tumor response. The IFP study will be finished at this time. You will also receive a phone call 30 days after the procedure to see if you have experienced any side effects.

This is an investigational study. Measuring tumor pressure before chemotherapy is investigational.

Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with histologic confirmation of malignant melanoma and skin lesion, and/or subcutaneous metastases.
  2. Males and Females >/= 18 years of age.
  3. Subject is willing and able to comply with scheduled visits and other trial procedures.
  4. Patients must be chemo-naive for malignant melanoma. Prior immunotherapy is allowed.
  5. Must be scheduled for systemic chemotherapy within 3 weeks of measurements
  6. Patient must have at least a one intact tumor or satellite lesion measuring >/= 10 mm in longest diameter.
  7. Patients must sign and date an informed consent.

Exclusion Criteria:

  1. Major surgery or radiation therapy close to the area where tumor IPF will be measured, within 4 weeks of starting the study treatment.
  2. Patients with the only melanoma skin lesions being localized in the area of the head and neck.
  3. High risk of bleeding with platelets </= 50,000 microliter, Partial thromboplastin time (PTT)/prothrombin time (PT) > 2 times upper limit of normal or patients on any type of anticoagulation.
  4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator or his designee would make the subject inappropriate for entry into this study.
  5. Patients will be excluded if they are receiving biological agents only.
  6. Pregnant or lactating females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IFP Measurement
Tumor interstitial fluid pressure (IFP) assessments
Procedure: Tumor Interstitial Fluid Pressure (IFP) assessments
The tip of a needle will be inserted in a skin lesion (similar to a biopsy needle) for up to 3 tumors. The needle is connected to a machine that reads the pressure inside the tumor. The whole process, including cleaning and numbing the lesion, will take about 3-4 minutes.
Device: Transducer-catheter SPC-320 + Amplifier
Transducer-tipped catheter Mikro-Tip SPC-320 and transducer Millar with Power Lab used to assess the interstitial fluid pressure in a malignant melanona nodule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility measured by proportion of patients in whom interstitial fluid pressure (IFP) can be measured
Time Frame: Baseline only + follow up 3 days after measurement
Baseline only + follow up 3 days after measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Jade Homsi, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Tumor Interstitial Fluid Pressure (IFP) assessments

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe