Vaccination Plus Ontak in Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00515528
First received: August 9, 2007
Last updated: September 4, 2013
Last verified: June 2013
  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:


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 2014
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:

  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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University of Chicago
ClinicalTrials.gov Identifier: NCT00515528     History of Changes
Other Study ID Numbers: 15232B
Study First Received: August 9, 2007
Last Updated: September 4, 2013
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 September 22, 2014