Vaccination Plus Ontak in Patients With Metastatic Melanoma

Study Description

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Brief Summary:

The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage.

Condition or disease	Intervention/treatment	Phase
Melanoma	Drug: 4-peptide melanoma vaccine; Drug: 4-peptide melanoma vaccine plus Ontak; Drug: ontak	Phase 2

Detailed Description:

This is an open-label, randomized phase II, single institution study comparing administration of a 4-peptide melanoma vaccine alone or post-Ontak, in patients with metastatic melanoma.

Treatment:

1. Cohort A: Vaccine alone. Patients will receive immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously on day 1. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression.
2. Cohort B: Ontak plus vaccine. Patients will receive Ontak (18 mcg/kg) intravenously on day -4 for one dose. On day 0, they will receive the first immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression. However, no further Ontak will be given.

Duration: Patients may remain on study until disease progression, unacceptable toxicity, patient choice to withdraw, or physician decision to discontinue therapy (due to intervening illness, poor patient compliance, or other situation that would increase patient risk).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma
Actual Study Start Date :	April 23, 2007
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	June 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; 4-peptide melanoma vaccine, ontak	Drug: 4-peptide melanoma vaccine; draft Drug: 4-peptide melanoma vaccine plus Ontak; draft Drug: ontak; draft
Experimental: 2; ontak	Drug: 4-peptide melanoma vaccine plus Ontak; draft

Outcome Measures

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Primary Outcome Measures :

1. To determine whether an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune response and lead to tumor shrinkage. [ Time Frame: draft ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Melanoma with evidence of metastatic disease
• Life expectancy of at least 12 weeks.
• Karnofsky performance status index of greater than or equal to 80%.
• Adequate hematopoietic, renal, and hepatic function, defined as:
• Patient must express HLA-A2
• Tumor biopsy: patient must agree to undergo biopsy of accessible tumor before and after therapy, when feasible, to study tumor cell properties and characteristics of immune cells.
• EKG without evidence of arrhythmia or changes that indicate acute ischemia.
• Pulse oximetry showing oxygen saturation of at least 90% on room air.

Exclusion Criteria:

• Significant cardiovascular disease, or cardiac arrhythmia requiring medical intervention.
• Pregnant or nursing women.
• Biological therapy in the 4 weeks prior to the start of dosing.
• Patients with intrinsic immunosuppression, including seropositivity for HIV antibody.
• Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C.
• Concurrent systemic corticosteroids (except physiologic replacement doses)or other immunosuppressive drugs (eg. cyclosporin A).
• Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent.
• Active or history of autoimmune disease
• Active gastrointestinal bleeding or uncontrolled peptic ulcer disease.
• Presence of untreated brain metastases.

Contacts and Locations

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Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Eisai Inc.

Investigators

Principal Investigator:	Thomas Gajeweski, MD, PhD	University of Chicago

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Luke JJ, Zha Y, Matijevich K, Gajewski TF. Single dose denileukin diftitox does not enhance vaccine-induced T cell responses or effectively deplete Tregs in advanced melanoma: immune monitoring and clinical results of a randomized phase II trial. J Immunother Cancer. 2016 Jun 21;4:35. doi: 10.1186/s40425-016-0140-2. eCollection 2016.

Responsible Party:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00515528 History of Changes
Other Study ID Numbers:	15232B
First Posted:	August 13, 2007
Last Update Posted:	September 12, 2017
Last Verified:	September 2017

Keywords provided by University of Chicago:

metastatic melanoma

Additional relevant MeSH terms:

Melanoma; Nevi and Melanomas; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms	Neoplasms, Nerve Tissue; Vaccines; Denileukin diftitox; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents