Renal Cell CarcinomaPhase 2NCT01070186
Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma
A Phase 2 study testing Sunitinib, Tumor biopsy and Nephrectomy in people with Renal Cell Carcinoma, run by Jonsson Comprehensive Cancer Center.
Trial summary
This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Sunitinib, Tumor biopsy and Nephrectomy
- Type of treatment
- 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
- Oct 2010to not given
- Phase
- Phase 2
- 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 must be at least 18 years of age
- Must be eligible to undergo a radical or partial nephrectomy
- Clinical stage T1b, T2, T3, T4 and/or N1 disease as documented by abdomen/pelvis CT scan, or MRI and chest x-ray or CT chest
- Patients must have a performance status on the ECOG scale of 0-1
- Patients must have a pretreatment wbc > 3.0, granulocyte count > 1000/mm3, hemoglobin > 8.5 g/dL, platelet count > 100,000/mm3 and a normal PT and PTT
- Patients must have a serum creatinine < 2.0 mg/dL
- Patients must have adequate hepatic function with a serum bilirubin < upper limit of normal and AST/ALT < 2.5 x upper limit of normal
Who cannot join
- Radiographic evidence of metastatic disease
- Prior administration of immunotherapy/biotherapy/hormonal or radiation for renal cell carcinoma
- Active secondary malignancies (other than basal cell carcinoma of the skin)
- Serious, nonhealing wound, ulcer, or bone fracture
- Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or Grade II or greater peripheral vascular disease within 1 year preceding Day 0
- Any history or radiologic evidence of central nervous system disease
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- Active infection requiring parenteral antibiotics at the time of the first Sunitinib administration
- Current or recent (within the 10 days preceding Day 0) use of oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanency indwelling IV catheters), or aspirin
- Current, recent (within the 4 weeks preceding Day 0), or planned participation in another experimental drug study
- Screening clinical laboratory values:
- ANC of < 1000/uL
- Platelet count of < 100,000/uL
- Total bilirubin > 2.0 mg/dL
- AST or ALT > 2.5 times the upper limit of normal
- Serum creatinine of > 2.0 mg/dL
- Hemoglobin of < 9 gm/dL (may be transfused to maintain or exceed this level)
- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2
- Prolonged QTc interval on baseline EKG
- Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy)
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
- History of psychiatric disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
- Unable to take medication by mouth
About this study
Official title: Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma
This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Sunitinib, Tumor biopsy, Nephrectomy, Biomarkers
- Keywords
- nephrectomy, T1b, T2, T3, T4, N1, Kidney Cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent
50mg/day for 4 weeks
Tumor biopsyOther
Conducted prior to administration of sunitinib therapy
NephrectomyProcedure or surgery
Nephrectomy 2-4 weeks after last dose of Sunitinib
BiomarkersOther
Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery.
Biomarker evaluation of tissue prior to 4 week administration of Sunitinib
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | See intervention descriptions Receives: Drug: Sunitinib; Other: Tumor biopsy; Procedure: Nephrectomy; Other: Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recurrence after surgery for high risk localized disease.
Measured: 1 year
Secondary outcomes (3)
Toxicity of Sunitinib when administered as neoadjuvant therapy prior to surgery
Toxicities will be graded using the NCI Common Toxicity Criteria, version 3.0
Measured: 1 year
Effect of Sunitinib on pretreatment serum levels of Vascular Endothelial Growth Factor (VEGF). Tissue levels (biopsy and pathological specimen) of total VEGF, HIF-alpha, microvessel density, and apoptotic indices (TUNNEL Staining)
Measured: 1 year
Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startOct 2010
Why it stopped: No participants were enrolled.
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 Jonsson Comprehensive 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Fairooz Kabbinavar, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070186
- Sponsor's protocol ID
- 09-07-068
- Status last verified
- Jul 2012
- First submitted
- 16 Feb 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01070186
- Acronym / sponsor ID
- 09-07-068
- Conditions
- Renal Cell Carcinoma
- Keywords
- nephrectomy, T1b, T2, T3, T4, N1, Kidney Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2010
- First posted
- 17 Feb 2010 (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.
This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Sunitinib, Other: Tumor biopsy, Procedure: Nephrectomy, Other: BiomarkersSee intervention descriptions |
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 must be at least 18 years of age
- Must be eligible to undergo a radical or partial nephrectomy
- Clinical stage T1b, T2, T3, T4 and/or N1 disease as documented by abdomen/pelvis CT scan, or MRI and chest x-ray or CT chest
- Patients must have a performance status on the ECOG scale of 0-1
- Patients must have a pretreatment wbc > 3.0, granulocyte count > 1000/mm3, hemoglobin > 8.5 g/dL, platelet count > 100,000/mm3 and a normal PT and PTT
Key exclusion criteria (23 listed)
- Radiographic evidence of metastatic disease
- Prior administration of immunotherapy/biotherapy/hormonal or radiation for renal cell carcinoma
- Active secondary malignancies (other than basal cell carcinoma of the skin)
- Serious, nonhealing wound, ulcer, or bone fracture
- Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or Grade II or greater peripheral vascular disease within 1 year preceding Day 0
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: Sutent50mg/day for 4 weeks | Drug | Treatment |
| Tumor biopsyConducted prior to administration of sunitinib therapy | Other | Treatment |
| NephrectomyNephrectomy 2-4 weeks after last dose of Sunitinib | Procedure or surgery | Treatment |
| BiomarkersBiomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery. Biomarker evaluation of tissue prior to 4 week administration of Sunitinib | Other | Treatment |
Primary outcome
Time to clinical recurrence after surgery for high risk localized disease.
Time frame: 1 year
3 secondary outcomes
Toxicity of Sunitinib when administered as neoadjuvant therapy prior to surgery
Time frame: 1 year
Effect of Sunitinib on pretreatment serum levels of Vascular Endothelial Growth Factor (VEGF). Tissue levels (biopsy and pathological specimen) of total VEGF, HIF-alpha, microvessel density, and apoptotic indices (TUNNEL Staining)
Time frame: 1 year
Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib.
Time frame: 1 year
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 31 Jul 2012.
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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.
Fairooz Kabbinavar, M.D. principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib, Tumor biopsy and Nephrectomy in people with Renal Cell Carcinoma, run by Jonsson Comprehensive 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 23 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 31 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to clinical recurrence after surgery for high risk localized disease. (time frame: 1 year). 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 31 Jul 2012.