None listed
Conditions
Brief summary
Melanoma is the least common but the most life-threatening of all skin cancers, accounting for only about 4% of all cases but causing 79% of skin cancer deaths. Whilst early stage melanoma can be successfully treated by surgical removal, few effective treatments exist for melanoma which has progressed to a later stage. The purpose of this study is to investigate the effect of Coramsine® in patients with late stage melanoma as well as evaluate the safety and tolerability of the drug. Also, the effect of Coramsine on Progression Free Survival will be assessed (this is defined as the length of time during and after treatment that the cancer does not grow and includes the amount of time patients have experienced a complete response or a partial response, as well as the amount of time patients have experienced stable disease).
Sponsors
Solbec Pharmaceuticals Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of stage IV or unresectable stage III Melanoma 2. Patients with bi-dimensionally measurable disease according to RECIST criteria 3. Patients who are able and willing to provide written informed consent to participate in the study. 4. Patients must have adequate haematological, hepatic and renal function 5. ECOG Performance status of 0-2. 6. Life expectancy of at least 16 weeks. 7. Fertile males and females must agree to the use of an adequate form of contraception. Negative pregnancy test is required in female patients of child-bearing potential.
Exclusion criteria
1. Patients with an active infection requiring oral or intravenous antibiotics 2. Patients with significant cardiac or pulmonary disease or evidence of any other significant medical condition, which in the opinion of the principal investigator could impair the ability of the patient to participate in the trial. 3. Patients with recent (< 6 months) peptic ulcerations or upper GI bleeding. 4. Pregnant or lactating women. 5. Reactions to the Solanum species (potatoes, tomatoes, aubergines and capsicum). 6. History of adverse reactions to related compounds. 7. Active brain or other CNS metastases. Stable/controlled brain metastases are permitted following treatment with surgery or radiation therapy. A minimum of 4 weeks must have elapsed since surgical or radiation treatment of brain metastases. 8. Unwilling/unable to have a venous access device inserted. 9. Known seropositive to HIV, Hepatitis B or Hepatitis C 10. Any other active malignancy 11. Patients must not have had any radiotherapy for 3 weeks prior to entering the study, and must be fully recovered from the acute effects of any prior radiotherapy. 12. Patients must not have greater than 2 previous regimens of chemotherapy treatment for Melanoma. Prior treatment with cytokines, vaccines, antiangiogenic agents or signal transduction inhibitors is permitted. 13. Patients must not have had any other tumour treatment medications for 30 days prior to entering the study. 14. Patients must not be actively receiving any other investigational therapy, nor received any experimental agents within the previous 30 days. 15. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Outcome results
None listed