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.
National Health & Medical Research Council
24 participants
Feb 1, 2003
Interventional
Conditions
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
Inclusion Criteria3
- Patients of either sex with histologically confirmed melanoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Non-resectable, low volume metastatic melanoma that is measurable and which has failed chemotherapy or where chemotherapy has not been recommended. Patients may be rendered low volume by partial surgical resection of their disease
Exclusion Criteria10
- No concomitant malignancy except for basal or squamous cell carcinoma of the skin or cone biopsied carcinoma of the cervix.
- Chemotherapy or immunotherapy in the past four weeks or previous radiation therapy to target lesions.
- Central Nervous System (CNS), spinal or bone metastases as the sole site of metastases.
- Concomitant pregnancy.
- Serum creatinine >15mmol/L or raised bilirubin due to melanoma.
- Concomitant infections or other serious medical illness.
- Concomitant steroid or other immunosuppressive therapy.
- Other serious illness requiring therapy unrelated to cancer.
- Patients who are Human immunodeficiency virus (HIV) positive, Hepatitis B sag, Hepatitis C positive. (All formally screened)
- Patients with cardiac or pulmonary impairment assessed from history and Eloectrocardigram (ECG).
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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-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.
Locations(1)
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ACTRN12608000355370