A Pilot Study Assessing the Feasibility and Safety of Measuring Interstitial Fluid Pressure (IFP) in Patients With Advanced Malignant Melanoma Before Starting Systemic Treatment
18 Years
N/A
Both
Advanced Cancers, Melanoma
Trial Information
A Pilot Study Assessing the Feasibility and Safety of Measuring Interstitial Fluid Pressure (IFP) in Patients With Advanced Malignant Melanoma Before Starting Systemic Treatment
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.
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 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility measured by proportion of patients in whom interstitial fluid pressure (IFP) can be measured
Outcome Time Frame:
Baseline only + follow up 3 days after measurement
Safety Issue:
No
Principal Investigator
Jade Homsi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2009-0120
NCT ID:
NCT01003626
Start Date:
March 2010
Completion Date:
March 2011
Related Keywords:
- Advanced Cancers
- Melanoma
- Advanced cutaneous melanoma
- Tumor Pressure
- Tumor IFP
- Interstitial Fluid Pressure
- IFP
- Transducer-tipped catheter Mikro-Tip SPC-320
- Transducer Millar
- Power Lab 8/30 amplifier
- Melanoma
- Neoplasms
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