Clinical trial NCT01189383: IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma
Official title: IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Melanoma Stage III
Malignant Melanoma Stage IV
Keywords: Melanoma
Vaccine
Dendritic Cell
Immune response
Safety
Efficacy
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2010-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to gather data on feasibility as well as immune and clinical efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or stage IV melanoma

Detailed description: IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a very important role in cancer immunotherapy. A desirable property for a dendritic cell vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved immunotherapy product.

Eligibility criteria: Inclusion Criteria:

* HLA A201 + phenotype
* Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease at study entry
* Age: 21-75 years
* ECOG performance status 0-1
* Adequate marrow function
* Adequate hepatic function
* Adequate renal function
* Written informed consent

Exclusion Criteria:

* Subjects with measureable non-resectable melanoma
* Subjects who have had chemotherapy less than 4 weeks before starting trial
* Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial
* Subjects who received IL2 less than 4 weeks before starting trial
* Subjects with a baseline LDH greater than 1.1 times the ULN
* Subjects who are HIV positive
* Female subjects who are pregnant
* Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial
* Subjects who have asthma and/or are on treatment for asthma
* Subjects with angina pectoris
* Subjects with congestive heart failure
* Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or thyroiditis
* Subjects with active infections including viral hepatitis
* Subjects with a history of neoplastic disease othe than melanoma within the last 5 years
* History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin.
* Subjects who present with open wounds

Primary outcomes:
measure: Immune response
timeFrame: 14 weeks
Secondary outcomes:
measure: Quality of elicited melanoma specific CD8+ T cells
timeFrame: 14 weeks
measure: Breadth of melanoma specific immunity
timeFrame: 24 weeks
measure: Longevity of melanoma specific CD8+ T cell immunity
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Joseph Fay, MD
role: PRINCIPAL_INVESTIGATOR
References: