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Phase I/II study of peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with advanced malignant melanoma

Phase 1
Conditions
unresectable malignant melanoma
Registration Number
JPRN-UMIN000006629
Lead Sponsor
Keio University, School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients who have active other primary malignancies 2)Patients who have past history of severe allergy 3)Patients who have severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes) 4)Patients who have pleural effusion or pericardial fluid requiring treatment 5)Patients who are pregnant or nursing 6)Male hope to impregnate 7)Carrier of HBV, HCV, HTLV-1, HIV and so on 8)Patients who have severe psychiatric disease 9)Patients who have past history of autoimmune disease 10)During treatment with immunosuppressive agents 11)During treatment with Disulfiram, Cyanamide, carmofur or Procarbazine Hydrochloride 12)Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Adverse events Response rate Progression free survival Overall survival
Secondary Outcome Measures
NameTimeMethod
Immune induction (Delayed type hypersensitivity DTH for melanoma-antigen peptide)
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