Clinical trial · Interventional
Gemcitabine and Carboplatin Followed By Laboratory-Treated T Lymphocytes in Treating Patients With Metastatic or Locally Recurrent Epstein-Barr Virus-Positive Nasopharyngeal Cancer
Phase II Trial Evaluating Efficacy of a Strategy Employing Combination Gemcitabine and Carboplatin Chemotherapy Followed by EBV-Specific Cytotoxic T-Lymphocytes in Patients With Metastatic or Locally Recurrent EBV-Positive Nasopharyngeal 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: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's T lymphocytes that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and carboplatin together with laboratory-treated T lymphocytes works in treating patients with metastatic or locally recurrent Epstein-Barr virus-positive nasopharyngeal 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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous Epstein-Barr virus-specific cytotoxic T lymphocytes | Biological | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| fluorescence activated cell sorting | Other | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| immunoenzyme technique | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Median progression-free survival (PFS 1), defined as the time from study enrollment to the time of radiological disease progression or death from any cause
Secondary outcomes (3)
- measure
- Median PFS 2, defined as the time from the start of induction immunotherapy to radiological disease progression or death from any cause
- measure
- Response rate, defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) after 4 courses of chemotherapy and the proportion of patients who achieve a further response after immunotherapy
- measure
- Clinical benefit rate of immunotherapy, defined as the proportion of patients who achieve CR, PR, or stable disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy-proven nasopharyngeal carcinoma (NPC) * WHO type 2/3 disease * Metastatic or locally recurrent disease * Epstein-Barr virus (EBV)-positive disease as confirmed by in situ hybridization assay or PCR amplification for EBV-encoded RNA expression * Radiologically measurable disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * ANC \> 1,200/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8 g/dL * Bilirubin \< 2 times upper limit of normal (ULN) * AST and ALT \< 3 times ULN * Creatinine clearance ≥ 40 mL/min * Corrected calcium normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent severe illness, including any of the following: * Chronic obstructive pulmonary disease * Ischemic heart disease * Active congestive cardiac failure * Active angina pectoris * Uncontrolled arrhythmia * Uncontrolled hypertension * No concurrent severe infections * HIV negative PRIOR CONCURRENT THERAPY: * No more than one line of prior chemotherapy for metastatic disease * No prior gemcitabine hydrochloride * Prior platinum agents allowed * At least 1 month since prior investigational therapy
References
Publications (0)
Data not yet available