Renal Cell CancerPhase 1NCT00694096
Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response
A Phase 1 study testing Sunitinib in people with Renal Cell Cancer, run by University of Utah at 1 site in United States.
Trial summary
This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must be 18 years or older for inclusion in this study. Since there is no experience with [F-18]FLT in children and it would be inappropriate to study individuals under the age of 18 until more safety data is available.
- After entry into the study, patients are expected to be followed for at least 2 months as part of standard of care.
- All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
- The patient, if female, must be postmenopausal for a minimum of one year or surgically sterile, or on one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera or Norplant. These criteria can be waived at the discretion of the investigator if the patient's tumor is considered life threatening and the one month wait required is not in the best interest of the patient. Negative pregnancy test is accepted.
- Pre-treatment laboratory tests for patients receiving [F-18]FLT must be performed within 21 days prior to study entry. These must be less than 4 times below or above the upper or lower limit range for the respective laboratory test. These will include liver enzymes (SGOT, SGPT, ALK Phos, GGT, LDH), bilirubin (direct and total), amylase, serum electrolytes, CBC with platelets and absolute neutrophil counts, prothrombin time, partial thromboplastin time, BUN, creatinine, and urinalysis.
- Pre-treatment radiological clinical scans/studies (Gd- enhanced MRI or CT to document metastatic renal cell carcinoma) must be performed within 30 days of study entry.
Who cannot join
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals or Gd used in MRI imaging. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- Patients who are pregnant or lactating or who suspect they might be pregnant.
- Adult patients who require monitored anesthesia for PET or MRI scanning.
- HIV positive patients due to the previous toxicity noted with FLT.
- Renal Insufficiency Exclusion for MRI contrast injection. All subjects will be screened as to their renal status and those patients with renal insufficiency will be excluded from undergoing a dynamic contrast enhanced MRI scan. This is in response to the recent association of MRI contrast agents with the development of Nephrogenic Systemic Fibrosis (NSF). The patient will have a creatinine value determined within 4 weeks prior to the proposed MRI scan and have a GFR determined from the creatinine value and other data that can be used at various websites to determine the GFR. If the GFR is greater than 60 ml/min/then the patient will be deemed eligible for contrast injection. If the GFR value is between 40 ml/min and 60 ml/min the risk versus benefit of performing the contrast injection will be discussed with the referring physician and the patient. If the GFR is less than 40 ml/min the dynamic contrast study will not be performed. The non-contrast MRI scan however will be obtained for anatomic reference for the PET studies.
- MRI exclusion criteria:
Show all 12Show fewer
- Presence of any ferromagnetic metallic implants or foreign bodies, including pacemakers and certain types of stents and orthopedic hardware.
- Claustrophobia or inability to remain stationary within MRI system for ~30-45 minutes.
- Inability to breath hold for periods of at least 20 seconds.
- Known history of adverse reaction to Gd chelate contrast agents.
- Pregnancy or breastfeeding.
- Non-imageable tumor, including tumors with smallest dimension less than 10mm or tumors located in regions excessively affected by susceptibility artifacts at bone- and air-tissue interfaces or motion artifacts due to peristalsis or pulsatile flow.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge 2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to determine an individual or more likely a set of imaging derived biomarkers that will accomplish several of the goals of the initiative which is providing funding for the study.
Read the detailed description
Our proposed clinical study will:
- Provide an exploratory yet reliable and validated cadre of imaging studies done in patients that yield a mechanistically-based understanding of: 1) predictive assays for clinical benefit from standard sunitinib therapy, 2) measurement of efficacy during standard sunitinib therapy, and 3) prognosis or other long term outcomes.
- Reveal a more detailed understanding of the in vivo mechanism of standard sunitinib therapy in patient tumors, mechanistic information on why particular functional imaging patterns are seen in treated patients, and clinical measures that are useful to physicians for decision making and for explanation of efficacy or outcomes for patients.
- Predict which patients may benefit from standard sunitinib therapy.
- Determine early in the course of treatment whether standard sunitinib therapy will be efficacious and whether this can be used in future comparable patients.
- Show the outcome of patients with standard sunitinib treatment.
- Shed further information on the biological mechanism for the rapid decrease of FDG uptake on FDG-PET imaging with standard sunitinib treatment.
It is our hypothesis that a set of biologically relevant imaging biomarkers (tumor metabolism assessed with dynamic FDG-PET; tumor proliferation assessed with dynamic FLT-PET; tumor blood flow assessed with H215O-PET and DCE MRI); tumor perfusion assessed with DCE-MRI; and tumor blood volume/volume of distribution assessed with H215O-PET and DCE MRI) in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks) will provide either alone or more likely in combination information that will predict which patients will most likely benefit from standard sunitinib therapy and that an early response assessment is possible that is predictive of a durable response to the therapeutic drug.
- Conditions
- Renal Cell Cancer
- Being tested
- Sunitinib
- 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.
SunitinibDrug
Also called Sutent®
Imaging studies with complete analyses will be provided on all patients prior to institution of sunitinib therapy as well as after therapy at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients or 4 weeks in 5 patients) after institution of sunitinib therapy at 37.5 mg orally/day.
Imaging studies include:
FDG-PET scans FLT-PET scans H215O-PET scans DCE-MRI scans
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Response
Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.
Measured: 4 weeks
Proliferative Response
Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.
Measured: 4 weeks
Secondary outcomes (1)
Overall Survival
The length of time from the start of treatment for a disease that patients are still alive; no time limit was imposed on data collection
Measured: 2399 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- John M Hoffman, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694096
- Sponsor's protocol ID
- HCI21897
- Status last verified
- Oct 2015
- First submitted
- 6 Jun 2008
- Last updated
- 1 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Horn KP, Yap JT, Agarwal N, Morton KA, Kadrmas DJ, Beardmore B, Butterfield RI, Boucher K, Hoffman JM. FDG and FLT-PET for Early measurement of response to 37.5 mg daily sunitinib therapy in metastatic renal cell carcinoma. Cancer Imaging. 2015 Sep 3;15(1):15. doi: 10.1186/s40644-015-0049-x.
PubMed 26335224
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response
- ClinicalTrials.gov ID
- NCT00694096
- Acronym / sponsor ID
- HCI21897
- Conditions
- Renal Cell Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Sep 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Posted 1 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge 2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to determine an individual or more likely a set of imaging derived biomarkers that will accomplish several of the goals of the initiative which is providing funding for the study.
Detailed description
Our proposed clinical study will:
- Provide an exploratory yet reliable and validated cadre of imaging studies done in patients that yield a mechanistically-based understanding of: 1) predictive assays for clinical benefit from standard sunitinib therapy, 2) measurement of efficacy during standard sunitinib therapy, and 3) prognosis or other long term outcomes.
- Reveal a more detailed understanding of the in vivo mechanism of standard sunitinib therapy in patient tumors, mechanistic information on why particular functional imaging patterns are seen in treated patients, and clinical measures that are useful to physicians for decision making and for explanation of efficacy or outcomes for patients.
- Predict which patients may benefit from standard sunitinib therapy.
- Determine early in the course of treatment whether standard sunitinib therapy will be efficacious and whether this can be used in future comparable patients.
- Show the outcome of patients with standard sunitinib treatment.
- Shed further information on the biological mechanism for the rapid decrease of FDG uptake on FDG-PET imaging with standard sunitinib treatment.
It is our hypothesis that a set of biologically relevant imaging biomarkers (tumor metabolism assessed with dynamic FDG-PET; tumor proliferation assessed with dynamic FLT-PET; tumor blood flow assessed with H215O-PET and DCE MRI); tumor perfusion assessed with DCE-MRI; and tumor blood volume/volume of distribution assessed with H215O-PET and DCE MRI) in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks) will provide either alone or more likely in combination information that will predict which patients will most likely benefit from standard sunitinib therapy and that an early response assessment is possible that is predictive of a durable response to the therapeutic drug.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 18 years or older for inclusion in this study. Since there is no experience with [F-18]FLT in children and it would be inappropriate to study individuals under the age of 18 until more safety data is available.
Key exclusion criteria (12 listed)
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals or Gd used in MRI imaging. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- Presence of any ferromagnetic metallic implants or foreign bodies, including pacemakers and certain types of stents and orthopedic hardware.
- Claustrophobia or inability to remain stationary within MRI system for ~30-45 minutes.
- Inability to breath hold for periods of at least 20 seconds.
- Known history of adverse reaction to Gd chelate contrast agents.
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 |
|---|---|---|
| SunitinibAlso: Sutent®Imaging studies with complete analyses will be provided on all patients prior to institution of sunitinib therapy as well as after therapy at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients or 4 weeks in 5 patients) after institution of sunitinib therapy at 37.5 mg orally/day. Imaging studies include: FDG-PET scans FLT-PET scans H215O-PET scans DCE-MRI scans | Drug | 1 |
Primary outcome
Metabolic Response
Time frame: 4 weeks
Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.
Proliferative Response
Time frame: 4 weeks
Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.
1 secondary outcome
Overall Survival
Time frame: 2399 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26335224Horn KP, Yap JT, Agarwal N, Morton KA, Kadrmas DJ, Beardmore B, Butterfield RI, Boucher K, Hoffman JM. FDG and FLT-PET for Early measurement of response to 37.5 mg daily sunitinib therapy in metastatic renal cell carcinoma. Cancer Imaging. 2015 Sep 3;15(1):15. doi: 10.1186/s40644-015-0049-x.
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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.
John M Hoffman, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sunitinib in people with Renal Cell Cancer, run by University of Utah 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 6 inclusion and 12 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 1 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Metabolic Response (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT00694096, which also lists 1 linked publication.
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 1 Dec 2015.