Vaccination Plus Ontak in Patients With Metastatic Melanoma - Full Text View

Purpose

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	Intervention	Phase
Melanoma	Drug: 4-peptide melanoma vaccine Drug: 4-peptide melanoma vaccine plus Ontak Drug: ontak	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Denileukin diftitox

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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:

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.
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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515528

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

No publications provided

Responsible Party:	Thomas Gajewski, Professor, University of Chicago
ClinicalTrials.gov Identifier:	NCT00515528 History of Changes
Other Study ID Numbers:	15232B
Study First Received:	August 9, 2007
Last Updated:	November 4, 2012
Health Authority:	United States: Food and Drug Administration

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
Denileukin diftitox
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013