None listed
Conditions
Brief summary
The primary purpose of this pilot trial is to examine the efficacy of decitabine in combination with carboplatin for the treatment of metastatic melanoma. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with metastatic melanoma which has been resistant to all previous treatments. Study details All participants enrolled in this trial will receive combination therapy with two chemotherapy agents, decitabine and carboplatin, according to the following treatment regime. On days 1-5, patients will receive a daily intravenous infusion of decitabine, followed by a single infusion of carboplatin on day 8. There will then be no treatment administered for the remainder of the cycle, until the regime is repeated starting on day 29. Researchers will perform tests on blood and tumour biopsy samples to examine the efficacy of the treatment in altering tumour cells so that they are more vulnerable to the immune system, and thus treating the cancer. It is hoped that information from this trial will provide preliminary information on the efficacy of decitabine in combination with carboplatin for the treatment of metastatic melanoma, and provide data to inform a larger clinical trial of this therapy.
Interventions
First month- Decitabine 7mg/m2 intravenous infusion (IVI)/day for 5 days (D1-D5) followed by Carboplatin Area under the curve (AUC) 5 as per the Calvert formula, IVI on D8; Week 3 and Week 4- no treatment.
Second month- repeat above starting at Week 5, Day 29.
All doses administered and logged on site by study staff.
Sponsors
University of Newcastle
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age>= 18 years 2. Before study enrolment written informed consent to participate in the trial must be given according to ICH/GCP and national/local regulations 3. Resistance to all approved treatments for melanoma 4. Tumour material is mandatory- tumour tissue selected must not be previously irradiated; treatment should start only after complete wound healing from surgery 5. Disease status before first treatment should be documented by full CT scan of brain, chest, abdo and pelvis and PET scan and MRI brain if indicated 6. BRAF mutation status 7. ECOG Performance Status 0,1,2
Exclusion criteria
1. mucosal or ocular melanoma 2. CNS metastases 3. Patient demonstrates inadequate organ function- hematologic, hepatic and renal 4. History of pneumonitis, interstitial lung disease, inflammatory bowel disease or active auto-immune disease that required systemic treatment in past 2 years (with use of disease modifying agents, corticosteroids or immune suppressive drugs) 5. History of immune related toxicity to previous immunotherapy of grade 2 or higher except endocrinology related toxicity that is treated and stable and on replacement therapy for adrenal, pituitary or thyroid deficiency (thyroxine, insulin or physiologic corticosteroid therapy allowed) 6. Diagnosis of immunodeficiency 7. Known history of HIV; active Hep B/C 8. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment 9. Patients who received treatment with live vaccines within 30 days prior to first dose of study medication 10. Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used and investigation device within 4 week prior to first dose of treatment 11. History of hematologic or primary solid tumour malignancy, unless no evidence of that disease for 5 years 12. Pregnancy and Contraception- Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose of study treatment 13. Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 120 days after the last dose of the study drug
Outcome results
None listed