Phase III trial of an immunotherapy for Stage III (AJCC) melanoma based on cultured autologous dendritic cells presenting autologous tumour cell antigens

Phase III trial of an immunotherapy for Stage III (AJCC) melanoma based on cultured autologous dendritic cells presenting autologous tumour cell antigens to test the effect on distant disease-free survival at 2 years, time to distant, or untreatable local recurrence and safety.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000590662

Acronym

MRPQ0161(A)

Enrollment

200

Registered

2005-10-05

Start date

2004-01-22

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention: autologous dendritic cell vaccine using autologous irradiated tumor cells as antigen source; Duration of intervention: two years or until disease recurrence.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Histologically confirmed melanoma of Stage III; ECOG status 0; Normal Haematolology; Acceptable Renal and Liver function parameters; Negative serology for HIV, Hep B and C;Informed written consent.

Exclusion criteria

Autoimmune disease or immunosuppressant use, Prior chemotherapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, post-operative complications which would preclude experimental vaccine therapy, Unsuccessful vaccine preparation, Clinically significant active infection, Uncontrolled systemic disease or medical problems, History of other malignancies (except for adequately treated and controlled non-melanomatic skin cancer or in situ cervical cancer), Pregnancy.

Outcome results