Vaccination Plus Ontak in Patients With Metastatic Melanoma

NCT00515528 | Terminated Phase 2 Results DMC

• 1 other identifier: 15232B
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

metastatic melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vaccine Alone

EXPERIMENTAL

Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.

Biological: 4-peptide melanoma vaccine

Vaccine plus Ontak

EXPERIMENTAL

Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration

Biological: 4-peptide melanoma vaccine; Drug: Ontak

Interventions

4-peptide melanoma vaccine BIOLOGICAL

Experimental cancer vaccine given as a shot under the skin once every two weeks

Vaccine Alone; Vaccine plus Ontak

Ontak DRUG

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

Vaccine plus Ontak

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Eisai Inc.: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• 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.

  PMID: 27330808 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Thomas F. Gajewski
• Organization: Department of Medicine

tgajewsk@medicine.bsd.uchicago.edu

773-702-4601

Study Officials

• Thomas Gajeweski, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: April 23, 2007
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 26, 2021
• Results First Posted: October 29, 2020

Record last verified: 2021-01

Locations

US (1)