Prostate Cancer: An internal, solid-malignancy model for vaccine therapy

Phase II/III trial of immunotherapy based on cultured autologous dendritic cells presenting synthetic autologous Prostate Specific Membrane Antigen (PSMA) peptides with processed Keyhole Limpet Haemocyanin (KLH) as helper antigen for hormone refractory prostatic cancer to assess safety and effect on disease progression.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000589684

Acronym

NUQM00J1

Enrollment

Registered

2005-10-05

Start date

2000-12-11

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

Single-blinded, 3 groups (randomised) examining two injection routes (intradermal and intravenous), of cultured autologous dendritic cells pulsed with soluble antigens. 6 injections with 4 weeks interval over 20 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Prostatic Cancer confirmed by biopsy, hormone refractory disease, HLA-A2+.

Exclusion criteria

Bone metastasis, ECOG status>1, PSA <4ng/ml, Abnormal haematologic parameters, Abnormal liver and renal function paramenters, history of autoimmune disease or immunosuppressive therapy, previous radiotherapy, protatectomy, or lymphadectomy, positive serology for HIV, Hep B or Hep C, Significant non-malignant disease, Psychiatric, addictive or any conditions which compromise ability to participate in this trial.

Outcome results