A Phase II Study of the Efficacy, Safety and Immunogenicity of OncoVEXGM-CSF in Patients With Stage IIIc and Stage IV Malignant Melanoma
1. 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 tumours that are accessible
for direct injection.
2. Tumours 0.5 to 10 cm in the longest diameter that are suitable for injection (i.e.
not bleeding or weeping).
3. Serum LDH levels <= 2.0 times the upper limit of normal.
4. Aged 18 years or more.
5. Performance status (ECOG) 0 or 1.
6. Clinically immunocompetent.
7. Recovered from prior therapy with at least 4 weeks since the last exposure to
chemotherapy or radiotherapy.
8. Total white cell count >= 3.0 x 10^9/L, platelet count >= 80 x 10^9/L.
9. Serum creatinine <= 0.2 mmol/L.
10. Bilirubin <= 1.5 times the upper limit of the normal range, AST/ALT equal to or less
than twice the upper limit of the normal range and alkaline phosphatase equal to or
less than twice the upper limit of the normal range.
1. 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.
2. 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.
3. 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.
4. Major surgery within the 14 days prior to entry to the trial.
5. Intercurrent serious infections within the 28 days prior to entry to the trial.
6. Life-threatening illness unrelated to cancer.
7. Treatment with antiviral agents within the 14 days prior to entry to the trial.
8. Uncontrolled congestive cardiac failure.
9. Clinically active autoimmune disease.
10. 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.
11. Known to test positive for HIV, hepatitis B or C or syphilis.
12. Patient only has injectable tumours that are not potentially resectable in the case
of tumour necrosis or swelling.
13. 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.
14. Corticosteroid use.