A pilot study of dendritic cell vaccination for stage IV melanoma following combination lymphodepleting chemotherapy.
- Conditions
- Stage IV MelanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12608000174381
- Lead Sponsor
- niversity of Queensland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study will be the safety and tolerability profile of combination immunodepleting chemotherapy and immunotherapy with autologous or allogeneic tumour pulsed DC. Safety and tolerability will be assessed using the national Cancer Institute Common Termionology Criteria for Adverse Events v3.0 (CTCAE)[Day 0, 7, 14, 21, weeks 4, 6, 8, 10, 12, 14, 16, 18.]
- Secondary Outcome Measures
Name Time Method Disease response will be documented using Response Evaluation Criteria in Solid Tumour (RECIST criteria) to provide preliminary clinical information on efficacy of study therapy[Day0, week 4, 10, 18]