Dendritic cell vaccination trial for hormone refractory prostate cancer with autologous tumour as the antigen

Dendritic cell vaccination trial for hormone refractory prostate cancer with autologous tumour as the antigen to assess safety and effect on disease progression.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000424606

Acronym

NRQ03J1

Enrollment

Registered

2005-09-16

Start date

2003-06-30

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

Cultured autologous dendritic cells (DC) processed to present autologous prostate cancer antigens for treatment of hormone refractory prostate cancer. Vaccines are administered at 2 weekly intervals for 10 weeks and then 6-weekly for up to one year.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Histologically proven prostatic Cancer, Maintenance hormone monotherapy, Serum PSA titres rising on 2 consecutive analyses, Minimum 5g of tumour-containing tissue.

Exclusion criteria

ECOG status >1, Significantly abnormal Haematological parameters, History of autoimmune disease or previous long-term use of immunosuppressive therapy, Positive serology for HIV, Hep C or B, Significant non-malignant disease, Psychiatric, addictive or any conditions which compromise ability to participate in trial.

Outcome results