A phase I/II study of dendritic cell vaccination with NY-ESO-1 and alpha-galactosylceramide in patients with metastatic melanoma.

Phase 1

Active, not recruiting

• Conditions: Malignant Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12612001101875
• Lead Sponsor: Malaghan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Patients must meet all the following criteria to be considered for inclusion in this study:
1. Able to give written informed consent and aged 18 years or over.
2. Histologically proven, fully resected American Joint Committee on Cancer (AJCC) Stage II, III, IV malignant cutaneous melanoma.
3. Full recovery from surgery (a minimum of 2 weeks should have elapsed since most recent surgery).
4. The patient must have been rendered disease free for no more than 12 months from surgery before study treatment.
5. ECOG performance status less than or equal to 2.
6. Geographically accessible to the Wellington Blood and Cancer Centre (WBCC) or prepared to travel regularly to Wellington for treatment and follow-up for the duration of the study.
7. Patients must have normal haematological, liver or renal parameters as indicated by:
i) Haemoglobin > 100 g/L
ii) Platelet count > 100 x109/L
iii) Neutrophil count > 1.5 x 109/L
iv) Lymphocytes > or = 0.8 x 109/L
v) Alanine Transaminase (ALT) less than or equal to 2.5 Upper Limit of Normal (ULN)
vi) Alkaline Phosphatase (ALP) less than or equal to 2.5 ULN
vii) Bilirubin less than or equal to 1.5 ULN
viii) Creatinine < 1.5 x ULN
8. If childbearing potential female, prepared to use contraception for the duration of the trial. Postmenopausal status is defined as meeting one or more of the following criteria:
i) over the age of 60
ii) bilateral oophorectomy
iii) aged up to and including 60 years of age with a uterus and amenorrhoea for at least 12 months
iv) aged up to and including 60 years of age without a uterus and with Follicle-stimulating hormone (FSH) >30 IU/L

Exclusion Criteria

Patients presenting with any of the following criteria are excluded from this study:
1. Mucosal or ocular melanoma.
2. Prior chemotherapy or radiotherapy for advanced melanoma within 6 weeks of randomisation to the study.
3. Received any prior immune therapy.
4. Pregnant or breastfeeding women.
5. Diagnosis of any other previous cancer in the past 5 years (except non-melanoma skin cancer or in situ cancer of the cervix).
6. Serology indicating active infection with Hepatitis B, C or Human immunodeficiency virus (HIV.)
7. Uncontrolled or unstable autoimmune disease such as Systemic Lupus Erythematosus (SLE), sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis
8. Previous use of long-term immunosuppressive therapy in recent months. Must have three months off steroids before entry into the study.
9. Patients with co-morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment (e.g. chronic obstructive pulmonary disease [COPD]). Steroid use less than or equal to 1 month is permissible.
10. Concurrent major organ dysfunction or unstable medical condition.
11. Unable to comply with study requirements as judged by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Counts of NY-ESO-1 peptide-specific T-cells.[These are measured by blood sampling at baseline, 14 days and 28 days after each vaccination. Enumeration of the antigen-specific T-cells will be measured by IFN-gamma ELISpot.];Counts of influenza peptide-specific T-cells.[These are measured by blood sampling at baseline, 14 days and 28 days after each vaccination. Enumeration of the antigen-specific T-cells will be measured by IFN-gamma ELISpot.]