ISRCTN26232057
Completed
未知
Combined Local Immunotherapy and Radiotherapy in metastatic Melanoma: an interventional single-arm trial
St George's Healthcare NHS Trust (UK)0 sites30 target enrollmentNovember 19, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Metastatic melanoma
- Sponsor
- St George's Healthcare NHS Trust (UK)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both males and females, aged 16 to 85 years
- •2\. Patients who have one or more malignant skin tumours confirmed histologically at diagnosis
- •3\. Patients with malignant skin tumours for whom other standard therapy options are no longer appropriate or have been refused by the patient
- •4\. Life expectancy of at least 3\-6 months
- •5\. Patients with a WHO performance status of 0, 1 or 2
- •6\. Patients who are informed of and are willing and able to comply with the home application of the Aldara® cream
- •7\. Patients who are willing and able to comply with the investigational nature of the study and who have signed a written informed consent form
- •8\. Patients who are willing to receive the number of intra\-lesional injections and biopsies required to complete the study
Exclusion Criteria
- •1\. Patients with unstable or severe current medical conditions or active, uncontrolled infection
- •2\. Patients with psychological or sociological conditions, addictive disorders or family problems which would preclude compliance with the protocol
- •3\. Patients undergoing therapy at study entry with other investigational agents that are directly immunosuppressive
- •4\. Patients having procreative potential who are not using adequate contraception
- •5\. Patients with untreated/uncontrolled brain tumours
- •6\. Patients with brain tumours which have been treated but which have not been stable for 3 or more months
- •7\. Patients with known hypersensitivity to Hiltonol®, IL\-2, Aldara®, cyclophosphamide (for patients 16 ? 30\) or any of the excipients
- •8\. Any condition, which, in the opinion of the investigator might interfere with the safety of the patient or evaluation of the study objectives
Outcomes
Primary Outcomes
Not specified
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