Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma

NCT ID: NCT00019682

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2011-05-31

Brief Summary

This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.

Detailed Description

PRIMARY OBJECTIVES:

I. To identify whether the addition of the peptide vaccine to high dose interleukin (IL)-2 (aldesleukin) can result in a clinical response rate which may be superior to that found in similar patients treated with high dose IL-2 alone.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity profile of patients treated on this trial, according to the regimen received.

II. To compare the disease free/progression free survival of patients treated on both arms of the study.

III. To determine the immunologic response experienced by patients who have received the peptide vaccination, as measured by changes in T-cell precursors from before to after treatment.

IV. To evaluate the quality of life of patients before and after high-dose IL-2.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive aldesleukin intravenously (IV) over 15 minutes every 8 hours for 12 doses.

ARM II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously (SC) on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2.

In both arms, treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

After completion of treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions

Recurrent Melanoma; Stage IIIA Skin Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IV Skin Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm I (aldesleukin)

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Group Type: EXPERIMENTAL

Aldesleukin

Intervention Type: BIOLOGICAL

Given IV

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin)

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Group Type: EXPERIMENTAL

Aldesleukin

Intervention Type: BIOLOGICAL

Given IV

gp100 Antigen

Intervention Type: BIOLOGICAL

Given SC

Montanide ISA 51 VG

Intervention Type: DRUG

Given SC

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Aldesleukin

Given IV

Intervention Type: BIOLOGICAL

gp100 Antigen

Given SC

Intervention Type: BIOLOGICAL

Montanide ISA 51 VG

Given SC

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Ro-236019; gp 100; gp100; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• Any patient with measurable metastatic (stage IV or locally advanced stage III) cutaneous melanoma and an expected survival of greater than three months will be considered
• Serum creatinine of 1.6 mg/dl or less
• Total bilirubin 1.6 mg/dl or less
• White blood cell (WBC) 3000/mm^3 or greater
• Platelet count 90,000 mm^3 or greater
• Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less then three times normal
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patients of both genders must be willing to practice effective birth control during this trial
• Pathologic confirmation of cutaneous melanoma; patients may enter the study with a pathologic diagnosis of cutaneous melanoma from any institution; all slides will be reviewed at National Institutes of Health (NIH) (department of Anatomic Pathology) and if the diagnosis is not confirmed, the patient will be excluded from the study
• Tissue type human leukocyte antigen (HLA) A0201

Exclusion Criteria

• Patients who have types of melanoma other than cutaneous, i.e. ocular or mucosal
• Patients who are undergoing or have undergone in the past 4 weeks any other form of therapy except surgery for their cancer, including radiation therapy to any site
• Patients who have active systemic infections, coagulation disorders, autoimmune disease or history of other major medical illnesses such as insulin dependent diabetes mellitus, cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary diseases and inflammatory bowel disorders
• Patients who have significant psychiatric disease which in the opinion of the principal investigator would prevent adequate informed consent or render immunotherapy unsafe or contraindicated
• Patients who require steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 4 weeks, or have used topical or inhalational steroids in the past 2 weeks
• Patients who are pregnant
• Patients who are known to be positive for viral hepatitis B or C (hepatitis B surface antigen [HBsAg] or anti hepatitis C virus [HCV]) or human immunodeficiency virus (HIV) (HIV antibody)
• Patients who have any form of primary or secondary immunodeficiency
• Patients who have received previous high dose IL-2 (> 600,000 IU/kg)
• Patients who have received previous gp100 vaccines
• Patients who have an abnormal stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia)
• Patients who have abnormal pulmonary function tests (forced expiratory volume in one second [FEV1] < 65% or forced vital capacity [FVC] < 65% of predicted)
• Patients who have brain metastasis or history of brain metastasis
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Schwartzentruber

Role: PRINCIPAL_INVESTIGATOR

IU Health Goshen Center for Cancer Care

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Kaiser Permanente Medical Center

Riverside, California, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Advocate Lutheran General Hospital.

Park Ridge, Illinois, United States

IU Health Goshen Center for Cancer Care

Goshen, Indiana, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

National Institutes of Health

Bethesda, Maryland, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Schwartzentruber DJ, Lawson DH, Richards JM, Conry RM, Miller DM, Treisman J, Gailani F, Riley L, Conlon K, Pockaj B, Kendra KL, White RL, Gonzalez R, Kuzel TM, Curti B, Leming PD, Whitman ED, Balkissoon J, Reintgen DS, Kaufman H, Marincola FM, Merino MJ, Rosenberg SA, Choyke P, Vena D, Hwu P. gp100 peptide vaccine and interleukin-2 in patients with advanced melanoma. N Engl J Med. 2011 Jun 2;364(22):2119-27. doi: 10.1056/NEJMoa1012863.

Reference Type: DERIVED

PMID: 21631324 (View on PubMed)

Other Identifiers

NCI-2012-02897

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000066963

Identifier Type: -

Identifier Source: secondary_id

99-C-0051

Identifier Type: OTHER

Identifier Source: secondary_id

T98-0085

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-02897

Identifier Type: -

Identifier Source: org_study_id

NCT00001801

Identifier Type: -

Identifier Source: nct_alias