Vaccination Plus Ontak in Patients With Metastatic Melanoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00515528 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 13, 2007
Last Update Posted
: September 12, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Drug: 4-peptide melanoma vaccine Drug: 4-peptide melanoma vaccine plus Ontak Drug: ontak | Phase 2 |
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).
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 |

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
|
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515528
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Thomas Gajeweski, MD, PhD | University of Chicago |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00515528 History of Changes |
Other Study ID Numbers: |
15232B |
First Posted: | August 13, 2007 Key Record Dates |
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 |