Status:
UNKNOWN
Gemcitabine and Carboplatin Followed By Laboratory-Treated T Lymphocytes in Treating Patients With Metastatic or Locally Recurrent Epstein-Barr Virus-Positive Nasopharyngeal Cancer
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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. Giv...
Detailed Description
OBJECTIVES: Primary * To determine progression-free survival (PFS 1) of patients with metastatic or locally recurrent Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma treated with gemcitab...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00690872
Start Date
July 1 2008
Last Update
June 29 2009
Active Locations (1)
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1
National Cancer Centre - Singapore
Singapore, Singapore, 169610