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

NCT00690872 | Unknown Phase 2

• 2 other identifiers: CDR0000577971SINGAPORE-07-27-NPC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

recurrent lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx

Outcome Measures

Primary Outcomes (1)

• 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)

• Median PFS 2, defined as the time from the start of induction immunotherapy to radiological disease progression or death from any cause

• 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

• Clinical benefit rate of immunotherapy, defined as the proportion of patients who achieve CR, PR, or stable disease

Interventions

autologous Epstein-Barr virus-specific cytotoxic T lymphocytes BIOLOGICAL

carboplatin DRUG

gemcitabine hydrochloride DRUG

polymerase chain reaction GENETIC

fluorescence activated cell sorting OTHER

immunoenzyme technique OTHER

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre - Singapore

Singapore, 169610, Singapore

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Carboplatin; Gemcitabine; Polymerase Chain Reaction; Flow Cytometry; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Toh Han Chong, MD, MBBS, MRCP

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 5, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2014
• Last Updated: June 29, 2009

Record last verified: 2009-06

Locations

SG (1)