CompletedPhase 2ACTRN12608000355370

Phase 1/2 study of immunotherapy of melanoma with dendritic cells pulsed with melanoma peptides or tumour extracts

A phase 1/2 study to evaluate the effects of autologous dendritic cell (DC) vaccine (+ or - Interleukin-2) on respomse in patients with malignant melanoma.

Sponsor

National Health & Medical Research Council

Enrollment

24 participants

Start Date

Feb 1, 2003

Study Type

Interventional

Conditions

Disseminated American Joint Committee on Cancer(AJCC ) Stage IV melanoma or locally recurrent melanoma.Melanoma Metastatic Melanoma

Summary

Dendritic cells will be grown from metastatic melanoma patients' peripheral blood and used to present common tumour antigens (peptides) or tumour extracts as a vaccine. In addition, some patients will receive low dose IL-2 in addition to their vaccine. IL-2 has been shown to increase the life of cytotoxic lymphocytes generated in animal and human vaccines.

Eligibility

Sex: Both males and femalesMin Age: 17 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 study tests an immunotherapy treatment for melanoma using the patients own immune cells loaded with melanoma-specific proteins. It is for adults aged 17 to 85 with advanced melanoma that cannot be surgically removed and has not responded to chemotherapy. Participants receive injections of modified immune cells.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

1.Patients (pts) are stratifed by Tissue Typing & then randomised into 2 groups, the two groups are Autologous Dendritric Cells (DC) alone or Autologous DC's plus Interleukin. (IL-2) will be self-adm

1.Patients (pts) are stratifed by Tissue Typing & then randomised into 2 groups, the two groups are Autologous Dendritric Cells (DC) alone or Autologous DC's plus Interleukin. (IL-2) will be self-administered by sub cutaneous(sc) injection on inner thighs or lower abdomen at a dose of 1 million units/m2/day commencing 2 days after each DC injection and continuing for 5 days after the first 3 DC injections and 12 days after the 4th DC injections and 14 days after the final 3 vaccines.DC vaccine injections will be given at week 0,1,2,3,5,9,& 13.All patients will complete a follow up at week 14. Patients will be equally allocated 2X2 to IL2. Patients will be required to have Computer Tomography (CT's) and Immunological blood examinations.DC are extracted from the patients blood.