Clinical trial · Interventional
Lymphocyte Therapy in Treating Patients With Kidney Cancer
Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma
NCT00002589CI-TRIAL-00013055unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may help them kill more cancer cells when they are put back in the body. PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| aldesleukin | Biological | Aldesleukin | ALIAS |
| muromonab-CD3 | Biological | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Survival as measured by Kaplan-Meier method at 5 years
- measure
- Onset of recurrence as measured by Kaplan-Meier method at 5 years
- measure
- Safety as measured by NCI Common Toxicity Criteria at completion of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically documented and completely resected stage III or stage IV renal cell carcinoma, clinically staged within 2 months prior to initiation of therapy * No evidence of nephrotic syndrome PATIENT CHARACTERISTICS: Age: * Over 16 Performance status: * ECOG 0-2 Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count 50,000/mm3 to 500,000/mm\^3 * Hemoglobin at least 10 g/dL * No hematologic abnormalities Hepatic: * PT no greater than 1.5 times control * PTT less than 1.5 times control * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 4.0 mg/dL * Calcium no greater than 12 mg/dL * No symptomatic hypercalcemia Cardiovascular: * No uncontrolled or severe cardiac disease, e.g.: * No myocardial infarction within 6 months * No congestive heart failure Other: * HIV negative * No significant organ dysfunction * No other serious medical illness that would limit life expectancy * No significant CNS disease including uncontrolled or untreated psychiatric or seizure disorders * No uncontrolled bacterial, viral, or fungal infection * No active peptic or duodenal ulcer * Adequate peripheral venous access required * No prior malignancy within past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * No other concurrent postnephrectomy adjuvant therapy Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * More than 1 week since prior corticosteroids (except as inhalation therapy for respiratory ailments or replacement for adrenal insufficiency) * No concurrent therapy with the following: * Estrogens (except as postmenopausal replacement therapy) * Androgens * Progestins * Antiestrogens * Antiandrogens * LHRH analogues or antagonists * Other hormones Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior solid organ allograft * More than 3 weeks since major surgery, including nephrectomy
References
Publications (0)
Data not yet available
No reference posted for this study.