Stage IIIc and stage IV malignant melanoma
Conditions
Interventions
Product Name: ONCOVEX GM-CSF
Pharmaceutical Form: Solution for injection
Current Sponsor code: ONCOVEX GM-CSF
Concentration type: range
Concentration number: 3x10e7 pfu/ml-2x10e8 pfu/ml
Product Name:
Sponsors
BioVex Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histologically proven stage IIIc (including two or more palpable lymph nodes, extracapsular or in-transit metastases) or stage IV melanoma that is not eligible for curative surgery and who have one or more tumour nodules that are accessible for direct injection. If possible, historical tissue blocks will be obtained for histological confirmation of the diagnosis by a third party pathologist. - Tumours 0.5 to 10 cm in the longest diameter that are suitable for injection (i.e. not bleeding or weeping). - Serum LDH levels = 2.0 times the upper limit of normal. - Aged 18 years or more. - Performance status (ECOG) 0 or 1. - Clinically immunocompetent. - Recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy. - Total white cell count = 3.0 x 109/L, platelet count = 80 x 109/L. - Serum creatinine = 0.2 mmol/L. - Bilirubin =1.5 times the upper limit of the normal range, AST/ALT = 2.0 times the upper limit of the normal range and alkaline phosphatase equal to or less than twice the upper limit of the normal range. - Able to give written informed consent and to comply with the protocol. - Have a life expectancy greater than 4 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Participation in any previous melanoma immunotherapy trial within one month prior to entry to this trial or any trial of any other investigational agent within the last month prior to entry to this trial. - Tumours to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumour swelling or erosion into a major vessel in the case of necrosis. - Pregnancy, lactation or lack of effective contraception in women of child-bearing potential; lack of effective contraception in men if the partner is of child-bearing potential; women must have been practising an effective contraceptive method for at least three months prior to entry in to the trial (hormonal contraception or intrauterine device in conjunction with a barrier method OR surgically sterilised). Men must use a condom or be surgically sterilised. - Major surgery within the 14 days prior to entry to the trial. - Intercurrent serious infections within the 28 days prior to entry to the trial. - Life-threatening illness unrelated to cancer. - Clinically active cerebral or any bone metastases. Patients with up to 3 asymptomatic (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy or gammaknife therapy, with no evidence of progression, and have not required steroids or anticonvulsant therapy, for at least two months prior to treatment with OncoVEX GM-CSF . Patients with up to 5 liver metastases may be enrolled, provided that no more than 1 lesion is >5 cm, and that the lesions are asymptomatic, meet RECIST criteria for SD for at least 1 month prior to the first dose of OncoVEX GM-CSF, ALT and AST are <2 times the ULN, bilirubin <1.5 mg/dL, ECOG score of 0-1, and there are no concurrent brain lesions. - Treatment with antiviral agents within the 14 days prior to entry to the trial. - Uncontrolled congestive cardiac failure. - Clinically active autoimmune disease. - Dermatoses involving or near to the tumours to be injected. Limb tumours may not be injected if active dermatoses are present on the same limb. Trunk and head and neck tumours must not be injected if dermatoses are present within 50 cm of the tumour. - Known to test positive for HIV, hepatitis B or C or syphilis. - Patient only has injectable tumours that are not potentially resectable in the case of tumour necrosis or swelling. - Previous history of malignancies of other types that have occurred or recurred within the previous 5 years with the exception of cone biopsied carcinoma of the cervix. - Corticosteroid use. Corticosteroids may be used acutely during the study as part of standard anti-emetic protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of OncoVEX GM-CSF in terms of tumour response rates ;Secondary Objective: To assess the safety of OncoVEX GM-CSF in terms of adverse events, clinical pathology and biodistribution and antibody responses to the vector. To assess the efficacy of OncoVEX GM-CSF in terms of immunological anti-tumour responses and in terms of time to tumour responses. To assess clinical efficacy in terms of median survival time and time to disease progression. ;Primary end point(s): The primary clinical efficacy endpoint of the trial will be tumour response rates. Median survival time, time to disease progression, and immunological responses to tumour antigens and time to tumour responses are secondary endpoints. | — |
Countries
United Kingdom
Outcome results
None listed