Advanced CancersNCT01003626
Interstitial Fluid Pressure (IFP) Pilot Study in Melanoma Patients
A study testing Tumor Interstitial Fluid Pressure (IFP) assessments and Transducer-catheter SPC-320 + Amplifier in people with Advanced Cancers and Melanoma, run by M.D. Anderson Cancer Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Melanoma
- What is being tested?
- Tumor Interstitial Fluid Pressure (IFP) assessments and Transducer-catheter SPC-320 + Amplifier
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologic confirmation of malignant melanoma and skin lesion, and/or subcutaneous metastases.
- Males and Females >/= 18 years of age.
- Subject is willing and able to comply with scheduled visits and other trial procedures.
- Patients must be chemo-naive for malignant melanoma. Prior immunotherapy is allowed.
- Must be scheduled for systemic chemotherapy within 3 weeks of measurements
- Patient must have at least a one intact tumor or satellite lesion measuring >/= 10 mm in longest diameter.
- Patients must sign and date an informed consent.
Who cannot join
- Major surgery or radiation therapy close to the area where tumor IPF will be measured, within 4 weeks of starting the study treatment.
- Patients with the only melanoma skin lesions being localized in the area of the head and neck.
- 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.
- 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.
- Patients will be excluded if they are receiving biological agents only.
- Pregnant or lactating females.
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Cancers, Melanoma
- Being tested
- Tumor Interstitial Fluid Pressure (IFP) assessments, Transducer-catheter SPC-320 + Amplifier
- Keywords
- 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
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Interstitial Fluid Pressure (IFP) assessmentsProcedure or surgery
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.
Transducer-catheter SPC-320 + AmplifierDevice
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
| Study group | Role | What they receive |
|---|---|---|
| IFP Measurement | Experimental | Tumor interstitial fluid pressure (IFP) assessments Receives: Procedure: Tumor Interstitial Fluid Pressure (IFP) assessments; Device: Transducer-catheter SPC-320 + Amplifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured by proportion of patients in whom interstitial fluid pressure (IFP) can be measured
Measured: Baseline only + follow up 3 days after measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jade Homsi, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003626
- Sponsor's protocol ID
- 2009-0120
- Status last verified
- Feb 2012
- First submitted
- 28 Oct 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Feasibility and Safety of Measuring Interstitial Fluid Pressure (IFP) in Patients With Advanced Malignant Melanoma Before Starting Systemic Treatment
- ClinicalTrials.gov ID
- NCT01003626
- Acronym / sponsor ID
- 2009-0120
- Conditions
- Advanced Cancers, Melanoma
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFP Measurement | Experimental | Procedure: Tumor Interstitial Fluid Pressure (IFP) assessments, Device: Transducer-catheter SPC-320 + AmplifierTumor interstitial fluid pressure (IFP) assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologic confirmation of malignant melanoma and skin lesion, and/or subcutaneous metastases.
- Males and Females >/= 18 years of age.
- Subject is willing and able to comply with scheduled visits and other trial procedures.
- Patients must be chemo-naive for malignant melanoma. Prior immunotherapy is allowed.
- Must be scheduled for systemic chemotherapy within 3 weeks of measurements
Key exclusion criteria (6 listed)
- Major surgery or radiation therapy close to the area where tumor IPF will be measured, within 4 weeks of starting the study treatment.
- Patients with the only melanoma skin lesions being localized in the area of the head and neck.
- 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.
- 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.
- Patients will be excluded if they are receiving biological agents only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor Interstitial Fluid Pressure (IFP) assessmentsThe 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. | Procedure or surgery | IFP Measurement |
| Transducer-catheter SPC-320 + AmplifierTransducer-tipped catheter Mikro-Tip SPC-320 and transducer Millar with Power Lab used to assess the interstitial fluid pressure in a malignant melanona nodule | Device | IFP Measurement |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Advanced Cancers
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
RecruitingPhase 2
Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer
Differentiated Thyroid Carcinoma
Active, not recruitingPhase 2
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Synovial Sarcoma, Myxoid Liposarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jade Homsi, MD study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Interstitial Fluid Pressure (IFP) assessments and Transducer-catheter SPC-320 + Amplifier in people with Advanced Cancers and Melanoma, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.