VMCL Melanoma Vaccine Treatment Phase II Study for Therapy of Patients with Advanced Stage IV Melanoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000425695

Acronym

VMCL Stage IV Melanoma Trial

Enrollment

Registered

2005-09-16

Start date

2000-01-01

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

Treatment of patients with Advanced Stage IV Melanoma using Vaccinia Melanoma Cell Lysate (VMCL). VMCL is currently an unregistered experimental agent that has been previously tested for treatment of stage III melanoma patients in a large Australian trial. This showed the agent to have a high degree of safety with very few adverse events. The scheduled treatment period will be 18 months, however, the treatment may be continued in individuals who show a significant clinical response.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Stage IV advanced melanoma with soft tissue/organ metastases; Absence of Brain Metastases; Absence of ocular melanoma associated retinopathy /iritis; Willingness to attend all scheduled clinical visits, tests and blood sampling.

Exclusion criteria

Solitary bone metastases; Large volume metastatic disease; Poor performance status; Pregnancy; Other malignancy.

Outcome results