Renal Cell CarcinomaNCT01026337
Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer
An observational study of Renal Cell Carcinoma and Stage III Renal Cell Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment. Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
- What is being tested?
- mutation analysis, pharmacological study and dynamic contrast-enhanced magnetic resonance imaging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Nov 2018
- Phase
- Observational
- 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
- AJCC stage IV or locally advanced (or inoperable) renal cell carcinoma for which archival tissue is available
- No prior anti-angiogenic therapy
- Prior radiation therapy to a symptomatic site of disease is allowed
- ECOG performance status of 0, 1 or 2
- White Blood Count >= 3,000/mm^3
- Absolute Granulocyte Count >= 1,500/mm^3
Show all 22Show fewer
- Platelet Count >= 100,000/mm^3
- Serum creatinine =< 2.0 x upper limit of normal (ULN) OR serum creatinine clearance (CrCl) >= 40 ml/min
- Total Bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert's disease)
- AST/ALT =< 2.5 x ULN (=< 5.0 ULN in the presence of liver metastases)
- INR =< 1.5 and a PTT within normal limits; patients who are taking warfarin must have documentation of an INR =< 1.5 and a PTT within normal limits prior to the initiation of anticoagulation to rule out a baseline coagulopathy
- Patient must not have pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication
- Patient must not have hypertension that cannot be controlled by medications (diastolic blood pressure >= 100 mm Hg despite optimal medical therapy)
- Patient must not have ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >= 2
- Patients must not receive any other investigational agents during the period on study
- Patients must not have a history or clinical evidence of brain metastasis; however, patients with resected or radiated brain metastases are eligible
- Patients must not have a serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- Patients must not have a serious intercurrent illness including, but not limited to, grade II or greater peripheral vascular disease within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's wort
- Women must not be pregnant or breast-feeding
- All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.
Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.
Read the detailed description
Primary Objectives:
- To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS).
II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI.
Secondary Objectives:
- To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib.
II. Samples will be collected for potential future exploratory analyses of pharmacokinetic and pharmacogenomic parameters.
Outline: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
- Being tested
- mutation analysis, pharmacological study, dynamic contrast-enhanced magnetic resonance imaging, sunitinib malate, immunohistochemistry staining method
- Keywords
- recurrent renal cell cancer
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation analysisGenetic
Correlative study
Also called pharmacological studies
Correlative study
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called DCE-MRI
Undergo DCE-MRI
sunitinib malateDrug
Also called SU011248, SU11248, sunitinib, Sutent
Given orally
immunohistochemistry staining methodOther
Also called immunohistochemistry
Correlative study
laboratory biomarker analysisOther
Correlative study
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate. Receives: Genetic: mutation analysis; Other: pharmacological study; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Drug: sunitinib malate; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC)
Secondary outcomes (1)
Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2015
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Keefe, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026337
- Sponsor's protocol ID
- UPCC 03809
- Other IDs
- NCI-2009-01414
- Status last verified
- Jun 2019
- First submitted
- 2 Dec 2009
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01026337
- Acronym / sponsor ID
- UPCC 03809
- Keywords
- recurrent renal cell cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 4 Dec 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.
Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.
Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.
Detailed description
Primary Objectives:
- To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS).
II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI.
Secondary Objectives:
- To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib.
II. Samples will be collected for potential future exploratory analyses of pharmacokinetic and pharmacogenomic parameters.
Outline: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | – | Genetic: mutation analysis, Other: pharmacological study, Procedure: dynamic contrast-enhanced magnetic resonance imaging, Drug: sunitinib malate, Other: immunohistochemistry staining method, Other: laboratory biomarker analysisPatients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- AJCC stage IV or locally advanced (or inoperable) renal cell carcinoma for which archival tissue is available
- No prior anti-angiogenic therapy
- Prior radiation therapy to a symptomatic site of disease is allowed
- ECOG performance status of 0, 1 or 2
- White Blood Count >= 3,000/mm^3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| mutation analysisCorrelative study | Genetic | Arm I |
| pharmacological studyAlso: pharmacological studiesCorrelative study | Other | Arm I |
| dynamic contrast-enhanced magnetic resonance imagingAlso: DCE-MRIUndergo DCE-MRI | Procedure or surgery | Arm I |
| sunitinib malateAlso: SU011248, SU11248, sunitinib, SutentGiven orally | Drug | Arm I |
| immunohistochemistry staining methodAlso: immunohistochemistryCorrelative study | Other | Arm I |
| laboratory biomarker analysisCorrelative study | Other | Arm I |
Primary outcome
Progression-free survival
Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC)
1 secondary outcome
Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
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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.
Stephen Keefe principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Stage III Renal Cell Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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 22 inclusion and 0 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: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival. The study lists 2 primary outcomes in all. 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 25 Jun 2019.