None listed
Conditions
Brief summary
The proposed research involves combining immunodepleting and immune modulatory chemotherapy with tumour specific immune therapy involving autologous dendritic cells. Hypothesis: 1. Pre-treatment with immunodepleting chemotherapy reduces the regulatory T-cell population 2. Reduction of regulatory T cell population augments the anticancer activities of immune therapy with DCs The aim of this pilot study is to provide information on the safety and tolerability of this regimen in patients with advanced melanoma whilst obtaining immunological data crucial to the design of larger studies evaluating this approach. We also hope to obtain preliminary information on whether pretreating patients with lymphodepleting chemotherapy augments the anticancer activities of immune therapy with DCs.
Interventions
Cyclophosphamide oral 200mg/day for 28 days,
8 x Tumour-pulsed dendritic cells (up to 6 x10E6 cells per injection) given intradermally at 2 weekly intervals.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects 1. Patients with metastatic stage IV metastatic melanoma not curable with standard therapy (radiotherapy or chemotherapy) and/or in whom standard therapy does not have proven survival benefits. This is relevant to the clinical state of the patient at the time of enrolment. 2. Written informed consent 3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (see Appendix 2) 4. Subject judged to be able to safely undergo leukapheresis 5. Age > 16. 6. Life expectancy estimated to be greater than 4 months
Exclusion criteria
1. Any concurrent therapy with possible activity against the patient’s malignancy with the exception of aminobisphosphonates (local radiotherapy on lesions not essential for study evaluation is allowed) 2. Concurrent therapy with any agent known to have immune modulating activity 3. Any therapy with possible activity against the patient’s malignancy in the month preceding administration of first dose of study therapy 4. Patient unable to undergo leukapheresis due to serious co-existing medical conditions (particularly cardiac or cardiovascular) or for other reasons 5. ECOG > 2 6. Pregnant or breast feeding or at risk for becoming pregnant within 3 months of enrolment 7. HIV, Hepatitis B or Hepatitis C positive 8. Patients who need immediate therapy because of a disease related complication or in whom a complication is predicted on clinical suspicion, and for whom some standard therapy is available and appropriate in the clinical condition. This does not apply to disease symptoms for which non disease specific therapy (e.g. analgesia) would be routinely offered. Patients excluded because of these criteria can become eligible after the immediate medical need has been fully treated with standard therapy and one month has elapsed.
Outcome results
None listed