Kidney CancerPhase 2NCT00853125
Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing therapeutic allogeneic lymphocytes and sunitinib malate in people with Kidney Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- therapeutic allogeneic lymphocytes and sunitinib malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 22 Feb 2014
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Primary lesion or metastatic site demonstrating clear cell variant with < 25% of any other histology
- Radiographically measurable disease by RECIST criteria
- Initiated treatment with sunitinib malate ≤ 6 weeks ago
- No radiographically detectable brain metastases by MRI or CT scan
- HLA-partially matched related donor available, as determined by serologic and/or DNA typing
- Appropriate HLA match (≥ 2/6 HLA A, B, DR match)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST ≤ 3.0 times ULN
- Calculated creatinine clearance ≥ 40 mL/min
- Cardiac ejection fraction ≥ 50%
- QTc interval < 500 msec by EKG
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- None of the following within the past 6 months:
- Myocardial infarction
- Severe/unstable angina
- Coronary/peripheral artery bypass graft
- Symptomatic congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- No ongoing ventricular cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia > 3 beats in a row)
- No ongoing atrial fibrillation
- No other malignancies within the past 3 years, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast
- No other concurrent serious illness
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic therapy for metastatic renal cell carcinoma
- No prior immunotherapy
- No prior VEGF-targeted or mTOR-targeted therapies
- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), St. John's wort, ketoconazole, dexamethasone, dysrhythmic drugs (e.g., terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
- No other concurrent investigational anticancer agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving sunitinib together with irradiated donor lymphocytes may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine progression-free survival of patients with metastatic clear cell renal cell carcinoma treated with sunitinib and irradiated allogeneic lymphocytes.
Secondary
- Determine rates and kinetics of clinical/radiographic response in these patients.
- Determine toxicities associated with treatment in these patients.
- Assess stable disease at 6 months in these patients.
- Assess overall survival of these patients.
OUTLINE: Patients receive oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning with course 2 of sunitinib malate, patients also receive irradiated allogeneic lymphocytes IV over 1 hour every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 60 days.
- Conditions
- Kidney Cancer
- Being tested
- therapeutic allogeneic lymphocytes, sunitinib malate
- Keywords
- clear cell renal cell carcinoma, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic allogeneic lymphocytesBiological
Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response
sunitinib malateDrug
Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib plus Irradiated Allogeneic Lymphocytes | Experimental | Not described Receives: Biological: therapeutic allogeneic lymphocytes; Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Determined as the time from treatment with combination sunitinib with irradiated allogeneic lymphocytes to progressive disease or death whichever occurred first. Progression is determined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 1 year.
Secondary outcomes (1)
Response Rate
Per response evaluation criteria in solid tumors criteria (RECIST v 1.0) for target lesions and assessed by MRI; Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Stable disease - not meeting criteria for response or progression.
Measured: Best responseFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completion22 Feb 2014
- Study completion22 Feb 2014
Why it stopped: Slow accrual
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.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Roger Strair, MD, PhD, Rutgers, The State University of New Jersey
- Investigators
- Roger Strair, MD, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853125
- Sponsor's protocol ID
- 0220080220
- Other IDs
- P30CA072720, CDR0000635763, 0220080220, 080708
- Status last verified
- Apr 2021
- First submitted
- 27 Feb 2009
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)
- ClinicalTrials.gov ID
- NCT00853125
- Acronym / sponsor ID
- 0220080220
- Conditions
- Kidney Cancer
- Keywords
- clear cell renal cell carcinoma, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- Feb 2009
- Primary completion
- 22 Feb 2014 (actual)
- Study completion
- 22 Feb 2014 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving sunitinib together with irradiated donor lymphocytes may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Determine progression-free survival of patients with metastatic clear cell renal cell carcinoma treated with sunitinib and irradiated allogeneic lymphocytes.
Secondary
- Determine rates and kinetics of clinical/radiographic response in these patients.
- Determine toxicities associated with treatment in these patients.
- Assess stable disease at 6 months in these patients.
- Assess overall survival of these patients.
OUTLINE: Patients receive oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning with course 2 of sunitinib malate, patients also receive irradiated allogeneic lymphocytes IV over 1 hour every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib plus Irradiated Allogeneic Lymphocytes | Experimental | Biological: therapeutic allogeneic lymphocytes, Drug: sunitinib malate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| therapeutic allogeneic lymphocytesPatients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response | Biological | Sunitinib plus Irradiated Allogeneic Lymphocytes |
| sunitinib malateSunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle. | Drug | Sunitinib plus Irradiated Allogeneic Lymphocytes |
Primary outcome
Progression-free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 1 year.
Determined as the time from treatment with combination sunitinib with irradiated allogeneic lymphocytes to progressive disease or death whichever occurred first. Progression is determined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
1 secondary outcome
Response Rate
Time frame: Best responseFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roger Strair, MD, PhD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutic allogeneic lymphocytes and sunitinib malate in people with Kidney Cancer, run by Rutgers, The State University of New Jersey 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?
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: stopped early, as of the sponsor's last update on 27 Apr 2021. 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 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?
Yes. Results are posted in the registry (first posted 31 May 2019). 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?
Progression-free Survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 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 27 Apr 2021.