AzTrials
AzTrials

Recurrent MelanomaPhase 3NCT00019682

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

A Phase 3 study testing Aldesleukin, gp100 Antigen and Montanide ISA 51 VG in people with Recurrent Melanoma and Stage IIIA Skin Melanoma, run by National Cancer Institute (NCI) at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aldesleukin, gp100 Antigen and Montanide ISA 51 VG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
19 sitesUnited States
Study dates
Dec 1999to May 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • National Institutes of Health

    Bethesda, Maryland, 20892

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • IU Health Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Advocate Lutheran General Hospital.

    Park Ridge, Illinois, 60068

  • Kaiser Permanente Medical Center

    Riverside, California, 92505

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Aldesleukin, gp100 Antigen, Montanide ISA 51 VG, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AldesleukinBiological

    Also called Ro-236019

    Given IV

  • gp100 AntigenBiological

    Also called gp 100, gp100

    Given SC

  • Montanide ISA 51 VGDrug

    Given SC

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00019682
Study groupRoleWhat they receive
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.
Receives: Biological: Aldesleukin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis
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.
Receives: Biological: Aldesleukin; Biological: gp100 Antigen; Drug: Montanide ISA 51 VG; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 years

Secondary outcomes (3)

  1. Progression Free Survival

    Progression free survival was compared between groups by means of Kaplan-Meier curves using the log-rank test to evaluate the significance of the difference between the arms.

    Measured: From the date of randomization until documentation of progression or last follow up, assessed up to 12 years

  2. Change in T-cell Precursors

    To measure change in T-cell precursors, PBMC were tested for reactivity by measuring gamma-interferon release after overnight coculture with peptide pulsed T2 cells. PBMC obtained after 4 cycles of study treatment were compared to pre treatment PBMC. A positive assay was defined as greater than 100pg/ml gamma-interferon release and at least twice the release (including all control peptides) by post treatment PBMC compared to pre treatment PBMC.

    Measured: Baseline to up to 12 years

  3. 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)

    QOL was measured before and after 2 cycles of treatment using 4 measures: FACT-G is a 27 item measure of QOL. A total score is calculated by summing across responses on a 5 point scale and ranges from 0-135, with higher scores indicating better QOL. FACT-F is 13 item measure of fatigue. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 0-52, with higher scores indicating less fatigue. SF-36 is a 36 item measure of self-reported health status. SF-36 is comprised of 8 subscales: physical function, role physical, bodily pain vitality, role emotional function, mental health, social function and general health. Summated scores range from 0-100, with higher scores indicating a better health state. SDS is a 13 item measure of symptom distress. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 13 to 65, with higher scores indicating more symptom distress.

    Measured: Baseline to up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1999
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019682
Sponsor's protocol ID
NCI-2012-02897
Other IDs
NCI-2012-02897, CDR0000066963, 99-C-0051, T98-0085
Status last verified
Nov 2017
First submitted
11 Jul 2001
Last updated
20 Nov 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21631324

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aldesleukin, gp100 Antigen and Montanide ISA 51 VG in people with Recurrent Melanoma and Stage IIIA Skin Melanoma, run by National Cancer Institute (NCI) at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Response Rate (Partial Response [PR] + Complete Response [CR]) (time frame: Up to 12 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00019682, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in