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Completed

NCT Number: NCT01189383

IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma

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

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Key information

Conditions

Malignant Melanoma Stage III Malignant Melanoma Stage IV Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IL15-DC Vaccine

Biological

Autologous dendritic cells manufactured with GM-CSF, IL15 and loaded with melanoma/HIV peptides and KLH; then activated with LPS and CD40 Ligand. Approximately 9 x 10^6 DCs will be injected (subcutaneously)total per vaccination visit. Patients will receive four vaccinations at weeks 0, 4, 8 and 12. At each scheduled vaccination the patient will receive a total of 3 injections, i.e., 3 mL injections at each of 3 anatomical locations.Injection sites are in upper and lower extremities. Subsequent DC injections will be rotated to different locations on the upper and lower extremities.

Primary outcomes

  1. Immune response

    Time frame: 14 weeks

Secondary outcomes

  1. Quality of elicited melanoma specific CD8+ T cells

    Time frame: 14 weeks

  2. Breadth of melanoma specific immunity

    Time frame: 24 weeks

  3. Longevity of melanoma specific CD8+ T cell immunity

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2010
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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