Gemcitabine and Carboplatin Followed By Laboratory-Treated T Lymphocytes in Treating Patients With Metastatic or Locally Recurrent Epstein-Barr Virus-Positive Nasopharyngeal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Treatments: Carboplatin; Gemcitabine

Criteria

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