Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

February 29, 2024 updated by: National Cancer Institute (NCI)

Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma

RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the clinical response of patients receiving DNA gp100 antigen alone or in combination with interleukin-2 for recurrent metastatic melanoma.

II. Identify the immunologic response in these patients prior to and after these treatments.

III. Determine the toxicity of these treatments in these patients.

PROTOCOL OUTLINE: Patients are accrued for the first three cohorts and the study proceeds to the final two cohorts if responses are observed.

Cohort I: Patients receive gp100 antigen intramuscularly (IM) into each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort II: Patients receive gp100 antigen intradermally (ID) at 5 sites on each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort III: Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses. If patients do not exhibit immunologic response or dose-limiting toxicity, they may receive a higher dose of gp100 antigen on subsequent courses.

Cohort IV: If cohorts I, II, or III do not produce an immune response and do not experience dose-limiting toxicity, patients receive a higher dose of gp100 antigen IM into each of 2 proximal extremities every 4 weeks for up to 4 doses.

Cohort V: Patients receive gp100 antigen IM or ID at the dose found to produce immunization once every 4 weeks for up to 4 doses. Patients also receive interleukin-2 IV over 15 minutes every 8 hours for 5 days (15 doses), beginning within 24 hours after gp100 antigen.

Patients with minor, mixed, or partial response or stable disease may receive additional courses of treatment following 3-4 weeks of rest. Patients receive a maximum of 12 courses.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL:

A maximum of 65 patients will be accrued for this study within 1 year.

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Bethesda, Maryland, United States, 20892
    - Surgery Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of metastatic melanoma that has failed standard therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Prior surgery allowed --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0 or 1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL ALT/AST less than 2 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major respiratory disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease No primary or secondary immunodeficiency HIV negative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Study Chair: Steven A. Rosenberg, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (Estimated)

March 5, 2007

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000066215
NCI-98-C-0086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.