Breast / Colon / Gastric / H&N / HBV Reactivation /
Leukemia / Liver / Lung / Myeloma / NPC / Prostate / QOL / SYM / VAC

Breast Cancer

(BRE012) A Randomized Double-Blind Phase 2 Study of Anastrozole Plus Lonafarnib (SCH66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Metastatic Breast Cancer (Sponsor: Schering Plough)

Eligibility:Subjects must be Postmenopausal women who have histologically-confirmed breast cancer with estrogen and/or progesterone receptor positive tumor and presence of distant metastatic disease. Subjects who have had one course of adjuvant hormonal therapy or treatment naïve are eligible. Patient must not have prior hormonal therapy or chemotherapy for the treatment of metastatic disease. Prior radiotherapy is permitted. Subjects must have adequate hepatic function and sufficient bone marrow reserve and with ECOG Performance Status of 0 or 1.
Objectives: To compare the activity (progression-free survival of Anastrozole in combination with Lonafarnib to that of Anastrozole in combination with placebo in subject with hormone-sensitive metastatic breast cancer.
Status: Active
Chair: Prof. Winnie Yeo

(BRE013) Randomized phase II study of the combination of oral vinorelbine with capecitabine versus a sequential regimen of oral vinorelbine and capecitabine versus the combination of docetaxel and capecitabine in patients with metastatic breast cancer previously treated with anthracyclines. (Sponsor: Pierre Fabre Medicament)

Eligibility: Female with histologically or cytologically confirmed adenocarcinoma of the breast and documented metastatic disease. She must be HER-2 negative disease on the primary tumour or on metastatic site, with measurable lesion and no prior chemotherapy for metastatic disease. Patient may have received prior radiotherapy and hormonal therapy and she must have adequate haematological function and hepatic functions at study entry.
Objectives: To evaluate simultaneously the response rate of the combination of oral vinorelbine with capecitabine, a sequential regimen of oral vinorelbine and capecitabine, and the combination of docetaxel and capecitabine for the first line treatment of patients with metastatic breast cancer, after prior anthracyclines containing (neo)-adjuvant regimen.
Status: Active
Chair: Prof. Winnie Yeo

(BRE014) A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib in Women with Early-Stage ErbB2 Overexpressing Breast Cancer

Eligibility: • Histologically or cytologically confirmed invasive breast cancer; primary tumor must be Tx or T1-4;
• Tumors that overexpress ErbB2;
• Completed adjuvant Chemo+ RT
Objectives: Primary: To determine whether adjuvant therapy with lapatinib will improve disease-free survival in women with early-stage ErbB2-overexpressing breast cancer.
Status: Active
Chair: Prof. Winnie Yeo

(BRE018) A Randomized phase 2 trial of double-blind, placebo, placebo controlled AMG 706 in combination with paclitaxel, or open-label bevacizumab in combination with paclitaxel, as first line therapy in women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer

Eligibility: Patient with age >= 18 years old. Histologically/cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. HER2 negative primary or metastatic tumor. ECOG ps: 0 or 1. Prior chemotherapy for locally recurrent or metastatic breast cancer is not allowed. Taxane (adj/neoadj) within 12 months of randomization is not allowed.
Objectives: Primary: To determine if treatment with paclitaxel plus AMG706 is superior to paclitaxel plus AMG706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer, based on objective response rates. Secondary: To estimate the difference in PFS time, clinical benefit, OS and duration of response between ARM A (Paclitqaxel plus AMG706 placebo) and AM B (Paclitaxel plus AMG 706)
To estimate the differences in ORR, PFS time, clinical benefit, OS and duration of response between ARM B and ARM C (paclitaxel plus bevacizumab)

Status: Active
Chair: Dr. WM HO

Colon Cancer

(COL011) A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX-4 plus cetuximab versus UFOX plus cetuximab as first-line therapy in subjects with metastic colorectal cancer

Eligibility:>=18 years old. Histologically confirmed adenocarcinoma of the colon or rectum. 1st occurence of metastatic disease (not curatively resectable)
Objectives: Primary objective: Progression-free survival. Secondary objectives: Response rates (CR and PR). Overall survival (OS). Safety. Quality of Life (FACT-C, EQ-5D). Treatment impact on social daily living and health care resource utilization.
Status: Active
Chair: Prof. Brigette Ma

(COL012) Intermittent versus continuous erlotinib with concomitant modified 'Xelox' (q3W) in first-line treatment of metastatic colorectal cancer

Eligibility: Male or female outpatients ages >=18 years. Be ambulatory and have an ECOG performance status of <=2. Patients with histological proof of adenocarcinoma of colon or rectum with evidence of metastatic disease. At least one unidimensionally measurable lesion with a diameter >=20mm using conventional CT or MRI scans or >=10mm using spiral CT scans.
Objectives: Primary objective: To evaluate two different schedules of Erlotinib in combination with a modified XELOX regimen in terms of response rate. Secondary objectives: To evaluate two different schedules of Erlotinib and modified XELOX regimen in terms of toxicity, their duration of response and effect on time to progression, progression-free survival and overall survival. To determine the effect of intermittent versus continuous Erlotinib administration on pharmacodynamic endpoints using tumor biopsies.
Status: Active
Chair: Prof. Brigette Ma

 

Gastric Cancer

(GAT005) An Open Label International Multi-center Phase 2 Activity and Safety Study of SU011248 in Patients with Advanced / Metastatic Gastric Progressing or Recurring After One Prior Chemotherapy(

Eligibility: • Histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (>50% extension in the stomach).• Patients must present with stage IV disease not amenable to surgery, radiation, or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred.• Patients must present with disease progression or recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose =4 weeks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion.
Objectives: To determine the antitumor activity of single-agent SU011248 at a dose of 50 mg orally
once daily for 4 consecutive weeks repeated every 6 weeks in patients with advanced /
metastatic gastric cancer, after failure of one prior chemotherapy regimen for advanced /
metastatic disease.
Status: Follow Up
Chair: Prof. Winnie Yeo

(GAT006) A Phase I/II study of Paclitaxel / Carboplatin / RAD001 as first line therapy for advanced adenocarcinoma of the stomach

Eligibility: Metastatic or unresectable loco-regional adenocarcinoma of the stomach. No prior chemotherapy for metastatic/recurrent disease, with good performance status and adequate hematologic, renal and hepatic function.
Objectives: To determine DLT and establish MTD of RAD001 in combination with paclitaxel and carboplatin in patients with advanced adenocarcinoma of the stomach.
Status: Active
Chair: Prof. Winnie Yeo

Head & Neck

(HAN001) A phase I study of Selective Intra-arterial High-dose Cisplatin Infusion and Accelerated Fractionation Radiotherapy for Non-metastatic Stage III and IV Head and Neck Squamous Cell Carcinomas

Eligibility: Patients with histologically proven of head and neck cancer, and have treatment-naïve. No evidence of distant metastasis. Stage III or IV disease.
Objectives: To determiine the maximum-tolerated dose (MTD) of IA cisplatin with accelerated fractionation radiotherapy.
Status: Follow-up
Chair: Dr. Kwok Hung Yu

Leukemia

(LUK001) A Phase I Study of CCI-779 in Combination with Imatinib Mesylate in Chronic Myelogenous Leukemia

Eligibility: Histologic confirmed Ph+ CML or Bcr-Abl positive CML. Chronic phase (CP) who failed imatinib. Accelerated phase (AP) +/- imatinib treatment. Blastic phase (BP) +/- imatinib treatment. Confirmed t(9;22) cytogenetics of FISH on bone marrow aspirate & biopsy within 28 days prior to registration. Age >18 years. Performance status 0-2 according to Southwest Oncology Group (SWOG). Life expectancy of >3 months. AP/BP are eligible whether they have receieved and/or failed imatinib or not. Untreated AP or BP patients. Will have imatinib 600mg daily for at least 14 days Tolerate imatinib prior to starting CCI-779.
Objectives: To determine: Safety and tolerability of CCI-779 given in combination with imatinib in patients with CML. Potential dose-limiting toxicities of this combination regimen. Hematologic and cytogenetic response rates.
Status: Active
Chair: Dr Kenny Lei

Liver Cancer

(HCC013) External Radiotherapy for Unresectable Hepatocellular Carcinoma under Respiratory Gating – Phase I/II Study

Eligibility: Histological confirmation of hepatocellular carcinoma: or radiological diagnosis (liver mass on CT scan) of hepatocellular carcinoma in hepatitis B carriers with increased serum alpha-fetoprotein (AFP)>500ng/dL. Unresectable hepatocellular carcinoma. Patient must be equal or over 18 years of age. Patient’s ECOG performance status must be 0-2. Total number of liver lesions must be 3 or less.
The sum of Largest Dimension (LD) for each lesion must be less than 10cm. No regional lymph node or distant metastasis. Criteria for Dose Volume Histogram (DVH) of normal liver must be fulfilled
Objectives: To determine the maximum radiation tolerance dose (MTD) for unresectable hepatocellular carcinoma using gated 3D conformal radiotherapy. To determine the local control (overall response plus stable disease) of unresectable hepatocellular carcinoma (HCC) treated with high dose 3D conformal radiotherapy under respiratory gating.
Status: Active
Chair: Prof Tony Mok

(HCC015) A Phase I/II Study of PXD101 in Patients with Unresectable Hepatocellular Carcinoma (HCC) with Pharmacokinetic and Pharmacodynamic Evaluation

Eligibility: Age>=18. Histologically or cytologically confirmed HCC, with ECOG <=2 and adequate haematologic, renal and hepatic function.
Objectives: To determine DLT and establish MTD of PXD101 in patients with inoperable HCC. To assess tumor response according to RECIST criteria.
Status: Active
Chair: Prof Winnie Yeo

(HCC018) A Randomized 2-Arm, Open Label, Phase II Study of BMS-582664, Administered Orally At A Dose of 800mg Daily or Doxorubicin Administered Intravenously At a Dose of 60mg/m2 Every 3 Weeks in Patients with Unresectable Hepatocellular Carcinoma.

Eligibility: Histologically proven or radiological evidence of unresectable HCC with measurable disease; male or female > 18 years old; with adequate bone marrow, hepatic and renal function. Patient must NOT have prior systemic therapy for HCC, including systemic chemotherapy, biological therapy or hormone therapy.
Objectives: To estimate the 6-month progression free survival rate in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior chemotherapy for HCC, treated with 800mg QD of BMS-582664 orally or with doxorubicin intravenously at a dose of 60mg/m2 Q3 weeks.
Status: Active
Chair: Prof Winnie Yeo

Lung Cancer

(LUN013) Randomized phase II study on locally advanced stage IIIb non-small-cell lung cancer: Concurrent chemo-radiation followed by gemcitabine alone or gemcitabine plus carboplatin or observation.

Eligibility: Patients with stage IIIB non-small cell lung cancer with completion of concurrent chemo-RT and achieve CR/PR or SD. Patients must have a performance status of ECOG 0-1 and with adequate organ function.
Objectives: The primary objective is to evaluate the survival rate of stage IIIb patients treated by concurrent chemo-RT followed by consolidation chemotherapy with either single agent gemcitabine or gemcitabine/carbolpatin combination or no further treatment. The second objectives are evaluate the patient one-year progressive rate, two-year survival rate, objective tumor response at the end of consolidation chemotherapy, qualitative and quantitative of consolidation chemotherapy, QOL.
Status: Follow Up
Chair: Prof. Tony Mok

(LUN024): A randomised, placebo-controlled, double-blind phase II study of sequential administration of Tarceva® (erlotinib) or placebo in combination with gemcitabine/platinum as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) (Sponsored by Roche)

Eligibility: Histological proven locally advanced or metastatic NSCLC patients with age >=18 years and had no prior chemotherapy for advanced disease.
Objectives: Non progression rate (CR+PR+SD). Objective response rate (CR+PR). Duration of response. TTP. Progression free survival. Overall survival.
Status: Active
Chair: Prof. Tony Mok

(LUN029): A phase 2, multicenter, open label, randomized trial of AMG 706 or Bevacizumab in combination with paclitaxel and carboplatin for advanced non-squamous non-small cell lung cancer (Sponsored by AMGEN Inc.)

Eligibility: Patients with age >=18 years. Histological confirmed advanced non-squamous NSCLC had no prior palliative chemotherapy.
Objectives: To estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and the paclitaxel/carboplatin plus bevacizumab arm (arm C) in subjects with advanced non-squamous NSCLC. To estimate the duration of response, PFS, and OS in each of the 3 treatment arms. To evaluate the safety and tolerability in the 3 treatment arms. To evaluate the pharmacokinetics of AMG 706 when administered with paclitaxel and carbolpatin in Arm A and B.
Status: Active
Chair: Prof. Tony Mok

(LUN034): A Phase II Study of Stereotactic Body Radiation Therapy (SBRT) under active breathing control for primary lung cancer and lung metastases

Eligibility: Eligible patients with lung tumours of size 5cm or less will receive SBRT under ABC. Age >= 18. ECOG performance status 0-2. Life expectancy > 6 months. No prior RT to the chest. For female, no pregnancy or lactation. No chemotherapy or targeted therapy within 4 weeks before commencement of RT or to be given concomitantly with RT. Adequate lung function: SaO2 at room air >= 90% and FEV1.0 >=700ml.
Objectives: Primary: To determine the local disease control rate at one year after SBRT.
Secondary: To observe the local disease control rate at two year and overall survival of patients. To evaluate the acute and late adverse effects of the treatment. To assess the intra-fractional and inter-fractional reproducibility of tumour position of the ABC device.
Status: Active
Chair: Dr. WK Tsang

(LUN035): A Multinational, randomized, double-blinded study comparing Aflibercept vs placebo in patients treated with 2nd line docetaxel for locally advanced or metastatic Non-Small Cell Lung Cancer

Eligibility: Inclusion criteria: Non-squamous histology/cytology. Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic NSCLC. ECOG performance status 0-2. Exclusion criteria: History of brain met., uncontrolled spinal cord compression, or carcinomatous meningitis. Prior Docetaxel treatment.
Patient refractory to 1st line paclitaxel-based therapy. Urine protein: creatinine ratio > 1 on morning spot urine or proteinuria > 500 mg/24h. Uncontrolled hypertension.
Evidence of clinically significant bleeding.
Objectives: Primary : To determine overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic NSCLC. Secondary: To compare efficacy of aflibercept to placebo for Progression free survival, Response rate , HRQL assessed by LCSS questionnaire. To assess the overall safety of the two treatment arms. To assess the pharmacokinetics of IV aflibercept on this patient population. To determine immunogenicity of IV aflibercept in all patients.
Status: Active
Chair: Prof. Tony Mok

Myeloma

(MYE001)A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma

Eligibility: Relapsed multiple myeloma.Measurable disease as defined by at least ONE of the following:
Serum monoclonal protein >=1.0 g by protein electrophoresis. >200 mg of monoclonal protein in the urine on 24 hour electrophoresis. Serum immunoglobulin free light chain >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio. Monoclonal bone marrow plasmacytosis >=30% (evaluable disease).
<=2 prior therapies. Stem cell transplantation and preceding induction therapy will be considered as one therapy. Patients must not be candidates for stem cell transplantation or should have had stem cells collected previously. >= 18 years of age. Life expectancy of >= 3 months. ECOG performance status of 0, 1 or 2.
Objectives: Primary objective: To assess the response rate of single agent Sunitinib in patients with relapsed multiple myeloma. Secondary objectives: To assess the toxicity of single agent Sunitinib in patients with relapsed multiple myeloma. To assess time to progression after initial response to Sunitinib. To assess the anti-angiogenic activity of Sunitinib in Myeloma.
Status: Active
Chair: Prof. Anthony Chan

Nasopharyngeal Carcinoma

(NPC008) A randomized phase II study of concurrent cisplatin-radiotherapy with or without neoadjuvant chemotherapy using taxotere and cisplatin in advanced nasopharyngeal carcinoma(NPC)

Eligibility: Patients with histologically proven of NPC, and have treatment-naïve NPC. No evidence of distant metastasis. Stage T3-4 any N, or any Stage T, N2-3.
Objectives: To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-RT with or without neoadjvant taxotere and cisplatin
Status: Follow-up
Chair: Prof. ATC Chan, Dr. P Teo

(NPC016) A Phase II Study of Concurrent Cetuximab-Cisplatin and Radiotherapy in the Treatment of Advanced Nasopharyngeal Carcinoma.

Eligibility: Patients with previously untreated, histologically confirmed NPC with: ‘T3 or T4, and any N, M0’, or ‘any T and N2 or N3, M0’. No evidence of distant metastases after staging investigations. Measurable disease must be present. Eastern Cooperative Oncology Group (ECOG) performance status of grade 0 or 1. Adequate bone marrow and organ reserve: absolute neutrophil count >= 1,500/mm3; platelets >= 100,000/mm3; hemoglobin > 8.0 g/dl; bilirubin <= 1.5 x the upper limit of normal (ULN); serum creatinine <= 1.2 x ULN and a calculated creatinine clearance of >= 50ml/min); alanine aminotransferase <= 3 x ULN. At least 18 years of age, of either sex.
Objectives: To determine the safety and feasibility of concurrent weekly cetuximab, low-dose cisplatin and radiotherapy (RT) in the treatment of patients with advanced NPC. To estimate the locoregional control rate at 3 months, progression-free survival and overall survival rates at 1 and 3 years, and overall disease-free survival and overall survival time. To examine the correlation between expression levels of the EGFR ligand TGF? and downstream signaling proteins (pMAPK, pAKT, Stat-3), EGFR gene amplification EGFR (intron 1) polymorphisms with treatment outcome.
Status: Active
Chair:Prof. Brigette BY Ma

(NPC019) Phase 2 Study Of SU011248 In Patients With Recurrent Or Metastatic Nasopharyngeal Carcinoma

Eligibility: Historically confirmed diagnosis of nasopharyngeal carcinoma (NPC)(either at initial diagnosis or at recurrence). Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy. Disease must be not amenable to potentially curative radiotherapy or surgery. Measurable disease according to RECIST. Age 18 or above; ECOG performance 0 or 1. Adequate bone marrow, renal and hepatic reserve.
Objectives: To evaluate the efficacy (clinical benefit rate) of single-agent SU011248 in patients with recurrent or metastatic nasopharyngeal carcinoma, and its impact on disease progression. To assess objective response rate. To assess duration of response. To assess progression-free survival and overall survival. To evaluate the safety and tolerability of SU011248. To evaluate SU011248 and SU012662 trough concentrations (Ctrough) and to correlate these plasma concentrations with efficacy and safety parameters. To study blood and tissue biomarkers and correlate with cancer-and treatment-related outcomes. To evaluate early anti-angiogenic activity of SU011248 on vivo as detected by dynamic contrast enhanced MRI.
Status: Active
Chair:Prof. Anthony Chan

(NPC020) A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer (RTOG-0615)

Eligibility: Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of Stage IIB-IVB (AJCC, 6th ed.) non-metastatic cancer of the nasopharynx; Histologic types WHO I-IIb/III; Zubrod Performance Status 0-1; Age >= 18; adequate bone marrow function defined as follows: WBC >= 4,000/cmm; Absolute neutrophil count (ANC) >= 1,500/ mm3; Platelets >= 100,000 cells/ mm3; Hemoglobin >= 9.0 g/dl. Adequate renal function defined as serum creatinine <= 1.5 mg/dl or calculated creatinine clearance >= 55 ml/min; adequate hepatic function defined as follows: total bilirubin <= 1.5 X UNL; aspartate aminotransferase <= 1.5 X UNL; alanine aminotransferase <= 1.5 X UNL; alkaline phosphatase <= 1.5 X UNL. International normalized ratio (INR) <= 1.5 X UNL and activated partial thromboplastin time (aPTT) <= 1.5 X UNL within 2 weeks prior to registration. Per the investigator’s assessment, the patient must have the nutritional and physical condition considered to be compatible with the proposed treatment regimen.
Objectives: To evaluate the safety and tolerability of bevacizumab (BV) plus chemoradiation. To determine the one- and two-year rates of local-regional progression, distant metastases, second primary tumors, progression-free survival, and overall survival for stage IIB-IVB nasopharyngeal cancer, WHO types I-IIb/III treated with 3D-CRT or IMRT concurrent with cisplatin (CDDP) and BV, followed by adjuvant CDDP plus 5-fluorouracil plus BV.
Status: Active
Chair:Prof. Anthony Chan

(NPC021) A Phase I Trial of 5Azacitidine and Suberoylanilide hydroxamic acid in Patients with Metastatic or Locally Recurrent Nasopharyngeal Carcinoma and Nasal NK-T cell Lymphoma

Eligibility: Biopsy proven nasopharyngeal carcinoma (WHO type 3) or extranodal NK-T cell non-Hodgkin’s lymphoma, nasal type; Patients must have metastatic disease or locally recurrent disease that is not amendable to surgical resection or further treatment with radiotherapy with curative intent; Patients must have metastatic disease or locally recurrent disease that has been treated with at least one regimen of chemotherapeutic agents after relapse; Patients must have disease that is accessible to biopsy via fine needle aspiration; Age >= 21 years; ECOG performance status <=2 (Karnofsky >=60%); Life expectancy greater than 6 months; Patients must agree to tumor biopsy to be carried out within 72 hours of the conclusion of the SAHA administration.
Objectives: Define toxicity profile of escalating doses of Suberoylanilide hydroxamic acid (SAHA) given in conjunction with a fixed dose of 5 Azacytidine (5AC) in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell Nasal Lymphoma; Define the biologically optimal dose of SAHA given in conjunction with a fixed dose of 5AC in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell Nasal Lymphoma based on evidence of EBV lytic induction in tumor biopsies and plasma; Study the effect of 5AC on the pharmacokinetic of SAHA
Status: Active
Chair:Prof. Anthony Chan

Prostate

(PST001): A Phase 2 Study of Fenretinide In Patients With Hormone Refractory Prostate Cancer (NCI Study)

Eligibility: Histological proven of prostate cancer with age >= 18 years and have not received prior chemotherapy.
Objectives: To evaluate the activity of Fenretinide in patients with advanced or metastatic hormone refractory prostate cancer (HRPC) by estimating the prostate specific antigen (PSA) response rate. To estimate the duration of PSA response, PSA-progression-free survival, overall survival, the toxicity of fenretinide in men with prostate cancer
Status: Follow Up
Chair: Prof. Tony Mok

Tumour Vaccine

(VAC002) A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Andara (MVA)-based Vaccine Encoding Epstein-Barr Virus Target Antigens

Eligibility: Histologically confirmed NPC, in which the presence of EBV within the malignant cells has been demonstrated by (1) EBER (EBV early RNA) in situ hybridisation in more than 50% of the malignant cells, or (2) undifferentiated or poorly differentiated carcinoma histology in association with a raised serum titer of IgA to EBV VCA. Patients in remission from disease, ie complete response (CR) or unconfirmed complete response (CRu). Completion of standard therapy for malignancy at least 12 weeks before trial entry. Age greater than 18 years. World Health Organisation (WHO) performance status of 0 or 1. Life expectancy of at least 4 months. Haematological and biochemical indices: Haemoglobin (Hb) > 10.0 g/dl; Lymphocytes >= 1.0 x 109/L; Neutrophils >= 1.5 x 109/L; Platelets (Plts) >= 100 x 109/L; Serum bilirubin <= 1.5 x upper normal limit; Serum alkaline phosphatase, ALT and/or AST <= 1.5 x ULN; calculated creatinine clearance >= 50ml/min
Objectives: To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine. To describe changes in the frequency of functional T-cell responses to MHC class I and II-restricted epitopes within EBNA1 and LMP2 in peripheral blood at sequential time-points before, during and up to nine months after the vaccination course. To assess changes in levels of EBV genome levels in plasma.
Status: Active
Chair: Prof. Anthony Chan