Clinical trial · Interventional
Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)
NCT00853125CI-TRIAL-00051461terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib malate | Drug | Sunitinib | ALIAS |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib plus Irradiated Allogeneic Lymphocytes
- interventionNames
- Biological: therapeutic allogeneic lymphocytes
- Drug: sunitinib malate
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 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.
- description
- 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.
Secondary outcomes (1)
- measure
- Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.