Clinical trial · Interventional
Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer
Phase II Study of Metastatic Cancer That Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes and Dendritic Cell Vaccination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to withdrawal of support from our collaborator.
Summary
Brief summary (as posted)
RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.
Conditions
Conditions (3)
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 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| anti-p53 T-cell receptor-transduced peripheral blood lymphocytes | Biological | — | UNRESOLVED |
| autologous dendritic cell-adenovirus p53 vaccine | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
- description
- Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
- interventionNames
- Biological: aldesleukin
- Biological: anti-p53 T-cell receptor-transduced peripheral blood lymphocytes
- Biological: autologous dendritic cell-adenovirus p53 vaccine
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- type
- EXPERIMENTAL
- label
- anti-p53 TCR PBL + DC + IL-2: Other histology
- description
- Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
- interventionNames
- Biological: aldesleukin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic cancer * Tumor overexpresses p53 as assessed by immunohistochemistry (i.e., ≥ 5% tumor cells stain positive for p53) * Biopsy must be available to evaluate p53 expression * Human leukocyte antigens 0201 (HLA-A\*0201) positive * Progressive or recurrent disease after prior standard therapy for metastatic disease * Patients with melanoma or renal cell cancer must have previously received aldesleukin * Patients with other histologies, not including hematologic malignancies, must have previously received first-line and second-line or higher systemic standard therapy (or effective salvage chemotherapy regimens) PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Life expectancy \> 3 months * Absolute neutrophil count \> 1,000/mm\^3 * White blood cell (WBC) \> 3,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal * Serum creatinine ≤ 1.6 mg/dL * Total bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL in patients with Gilbert's syndrome) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after completion of study treatment * Patients who have previously received ipilimumab or ticilimumab must have a normal colonoscopy with normal colonic biopsies * Human immunodeficiency virus (HIV) antibody negative * Hepatitis B antigen and hepatitis C antibody negative (unless antigen negative) * No primary immunodeficiency (e.g., severe combined immunodeficiency disease) * No active systemic infections * No history of severe immediate hypersensitivity reaction to any of the agents used in this study * No coagulation disorders * No myocardial infarction or cardiac arrhythmias * No history of coronary revascularization * No obstructive or restrictive pulmonary disease * No contraindications for high-dose aldesleukin administration * Left ventricular ejection fraction (LVEF) ≥ 45% in patients meeting any of the following criteria: * History of ischemic heart disease, * chest pain, * or clinically significant atrial and/or ventricular arrhythmias including, but not limited to, atrial fibrillation, * ventricular tachycardia, * or second- or third-degree heart block * At least 60 years of age * Forced expiratory volume 1 (FEV\_1) \> 60% predicted in patients meeting any of the following criteria: * Prolonged history of cigarette smoking (\> 20 pack/year within the past 2 years) * Symptoms of respiratory dysfunction * No other major medical illness of the cardiovascular, * respiratory, * or immune system PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * More than 4 weeks since prior and no concurrent systemic steroid therapy * More than 4 weeks since other prior systemic therapy * More than 6 weeks since prior ipilimumab
References
Publications (0)
Data not yet available