Vaccination Plus Ontak in Patients With Metastatic Melanoma

Melanoma Clinical Trial

Official title:

Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00515528
• Other study ID #: 15232B
• Status: Terminated
• Phase: Phase 2
• Start date: April 23, 2007
• Est. completion date: March 2016

Study information

• Verified date: January 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• 4-peptide melanoma vaccine
Experimental cancer vaccine given as a shot under the skin once every two weeks

Drug:
• Ontak
A single dose of Ontak given as an intravenous infusion over 30 minutes, 4 days before the first vaccine is given.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response Outcome	Proportion of Patients With a Best Response of Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).; Response was evaluated every 6 weeks based on Response Evaluation In Solid Tumor (RECIST) version 1.1.; Per RECIST v1.1 for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions	6 weeks