Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma
4 other identifiers
interventional
185
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 1999
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedFirst Submitted
Initial submission to the registry
July 11, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
November 20, 2017
CompletedNovember 20, 2017
November 1, 2017
11.4 years
July 11, 2001
December 2, 2016
November 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Best Response Rate (Partial Response [PR] + Complete Response [CR])
A complete response (CR) was defined as the disappearance of all clinical evidence of disease for at least 4 weeks. A partial response (PR) was defined as a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions could appear, and none could increase 25% or more.
Up to 12 years
Secondary Outcomes (3)
Progression Free Survival
From the date of randomization until documentation of progression or last follow up, assessed up to 12 years
Change in T-cell Precursors
Baseline to up to 12 years
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Baseline to up to 8 weeks
Study Arms (2)
Arm I (aldesleukin)
EXPERIMENTALPatients 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.
Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given SC
Ancillary studies
Ancillary studies
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Kaiser Permanente Medical Center
Riverside, California, 92505, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Advocate Lutheran General Hospital.
Park Ridge, Illinois, 60068, United States
IU Health Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
National Institutes of Health
Bethesda, Maryland, 20892, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
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.
PMID: 21631324DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Douglas Schwartzentruber
- Organization
- Indiana University Health
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Schwartzentruber
IU Health Goshen Center for Cancer Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2001
First Posted
January 27, 2003
Study Start
December 1, 1999
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 20, 2017
Results First Posted
November 20, 2017
Record last verified: 2017-11