Clinical trial · Interventional
Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
Phase I/II Study of Adoptive Immunotherapy Comprising Pyrophosphomonoester Antigen-stimulated T Cells, IL-2, and Nitrogen-containing Bisphosphonates in Patients With Stage IV Renal Cell Carcinoma
- 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: Cellular adoptive immunotherapy uses a person's white blood cells that are treated in the laboratory to stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may help the laboratory-treated white blood cells stay in the body longer. Drugs used in chemotherapy, such as zoledronic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cellular adoptive immunotherapy together with interleukin-2 and zoledronic acid may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cellular adoptive immunotherapy together with aldesleukin and zoledronic acid and to see how well it works in treating patients with stage IV kidney cancer and lung metastases.
Conditions
Conditions (2)
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 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Frequency and severity of adverse events based on NCI-CTCAE version 3.0
- measure
- Proportion of gd T-cells in peripheral blood
Secondary outcomes (2)
- measure
- Secondary doubling time of tumor growth
- measure
- Overall response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal carcinoma * Stage IV disease with lung metastases * Bidimensionally measurable lung metastases by CT scan * Meets 1 or more of the following criteria: * No change in disease status or progressive disease after prior aldesleukin administration for 3 months or more * Lung metastases after treatment with prior nephrectomy * Patients with clear cell renal carcinoma must have undergone nephrectomy prior to study entry * Patients with progression of metastatic lung cancer after nephrectomy also must have received interferon alfa for 3 months or more (prior to study entry) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 6 months * Leukocyte count ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Serum bilirubin ≤ 1.5 mg/dL * AST/ALT ≤ 2.5 times normal * Serum creatinine ≤ 1.7 mg/dL * LDH ≤ 1.5 times normal * Not pregnant nor nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection with hepatitis virus or HIV * No poorly controlled heart failure or arrhythmia * No hypercalcemia that require medication * No C-reactive protein with an infectious disease that requires medication PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior chemotherapy, radiation therapy, or biologic therapy * No prior bone marrow transplantation or organ transplantation * No concurrent steroid therapy * No concurrent antidepressant therapy
References
Publications (0)
Data not yet available