Clinical trial · Interventional
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Immunotherapy for Patients With Renal Cell Carcinoma
NCT00176501CI-TRIAL-00013328terminatedPhase 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: When irradiated donor lymphocytes are infused into the patient they may help the patient's immune system kill tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irradiated allogeneic lymphocytes
- interventionNames
- Biological: therapeutic allogeneic lymphocytes
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 5 years
- description
- With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.
Secondary outcomes (2)
- measure
- Rate and Kinetics of Clinical/Radiological Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of clear cell renal cell carcinoma * Metastatic disease * Measurable disease * Previously treated with high-dose aldesleukin OR not eligible for or refused such therapy * No brain metastases by MRI or CT scan * HLA-partially matched (e.g., ≥ 2/6 HLA A, B, Dr match) related donor available * Patients who have no partially matched immediate family member available are eligible if they have a fully HLA-matched donor PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Bilirubin ≤ 2 times upper limit of normal * Creatinine clearance ≥ 40 mL/min * AST ≤ 3 times ULN * Cardiac ejection fraction ≥ 45% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.