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Recurrent MelanomaPhase 1NCT01989559

Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery

A Phase 1 study testing gp100:209-217(210M) Peptide Vaccine, HPV 16 E7:12-20 Peptide Vaccine and Laboratory Biomarker Analysis in people with Recurrent Melanoma and Stage IA Skin Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

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

Official record
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Trial summary

This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Read more about this study

Who is it for?
Any age
What is being tested?
gp100:209-217(210M) Peptide Vaccine, HPV 16 E7:12-20 Peptide Vaccine and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Oct 2002to Sep 2013
Phase
Phase 1
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must have completed treatment on protocol 99-9 [T98-0081] "A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide Vaccine in HLA-A2.1+ Patients with a > 1mm Melanoma on Initial Biopsy;" patients are not required to have received every planned vaccine as long as the reason for stopping was not disease progression or dose limiting toxicity
  • Patients must be >= 12 months from their last vaccination with gp100 and be free of melanoma; patients who have remained continuously free of disease and patients who have had a recurrence that has been completely resected (stage IV no evidence of disease [NED]) are eligible
  • Patients must have a good performance status (Karnofsky performance status [PS] 80-100)
  • White blood cells (WBC) >= 3500/mm^3
  • Platelets (plt) >= 100,000/mm^3
  • Hemoglobin >= 9 gm/100 ml
Show all 12Show fewer
  • Serum creatinine =< 2 mg/dl
  • Total bilirubin =< 2.0 mg/dl
  • Patients must have recovered from any effects of major surgery and be free of significant systemic infection
  • Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment; men must avoid fathering a child while on treatment
  • Patients must give written informed consent prior to initiation of therapy
  • Patients with a history of psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy

Who cannot join

  • Patients must not have clinically detectable melanoma
  • Patients who require or are likely to require systemic corticosteroids for intercurrent illness are ineligible
  • Patients with any significant medical disease other than the melanoma, which in the opinion of the investigator would significantly increase the risk of immunotherapy, are ineligible
  • Patients should be free of any other cancers or deemed at low risk for their recurrence

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Providence Portland Medical Center

    Portland, Oregon, 97213

Other trials in United States

About this study

Official title: A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma

This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the toxicity of booster vaccination with the gp100 (gp100:209-217(210M) peptide vaccine) and human papilloma virus (HPV) peptides in Montanide ISA 51 or Montanide ISA 51 VG administered >= 12 months after the last immunization.

II. To measure the T-cell response to the modified gp100: 209-217 (210M) peptide and the unmodified native gp100 peptide following booster vaccination >= 12 months after the last immunization.

III. To measure the T-cell response to the control human leukocyte antigen (HLA)-A2 restricted clusters of differentiation (CD)8 epitope of papilloma virus HPV16E7:12-20 following booster vaccination >= 12 months after the last immunization.

IV. To perform detailed studies of the memory T cells persisting >= 12 months after immunization.

OUTLINE:

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 subcutaneously (SC) on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed up at 6 months, every 6 months for 5 years, and then annually thereafter.

Being tested
gp100:209-217(210M) Peptide Vaccine, HPV 16 E7:12-20 Peptide Vaccine, Laboratory Biomarker Analysis
Medical subject headings
Melanoma

What participants receive

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

  • gp100:209-217(210M) Peptide VaccineBiological

    Given SC

  • HPV 16 E7:12-20 Peptide VaccineBiological

    Also called HPV-16 E7(12-20) peptide, HPV-16E7(12-20) peptide vaccine, HPV16 E7(12-20) peptide, HPV16 E7(12-20) peptide vaccine

    Given SC

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT01989559
Study groupRoleWhat they receive
Treatment (vaccine therapy)ExperimentalPatients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 SC on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.
Receives: Biological: gp100:209-217(210M) Peptide Vaccine; Biological: HPV 16 E7:12-20 Peptide Vaccine; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Percentage of positive CD8+ T cells

    Characterized using three different in vitro assays. Fresh and cryopreserved peripheral blood mononuclear cells (PBMC) will be analyzed for gp100 peptide-specific CD8+ T cells using a fluorescinated, modified gp100, peptide-specific, A2-restricted tetramer binding assay and the interferon (IFN) gamma specific enzyme-linked immunosorbent spot (ELISPOT) and cytokine flow cytometry (CFC) assays.

    Measured: Up to 11 years

  2. Change in CD8+ T cell frequency

    Differences in immune parameters will be graphically depicted by means of density plots, frequency histograms, box and whisker-plots, dot-plots, trellis graphics (where appropriate) and other plots and graphs. Analyses of continuous variables will be performed first on the original frequency data. Goodness of fit statistics will be employed to determine whether assumptions underlying test statistics (e.g., normality) are satisfied. If assumptions for the test procedures are violated, then rank-transformed or arcsin-transformed data will be used. Probability tests will be two-sided.

    Measured: Up to 11 years

Timeline

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

  1. First posted21 Nov 2013 (estimated)
  2. Study startOct 2002
  3. Primary completionSep 2013
  4. Study completionSep 2013

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 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989559
Sponsor's protocol ID
NCI-2013-02097
Other IDs
NCI-2013-02097, PPMC-IRB-02-63, NCI-5925, CDR0000258479, 02-63, 5925, R21CA099265
Status last verified
Nov 2013
First submitted
18 Nov 2013
Last updated
26 Jan 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gp100:209-217(210M) Peptide Vaccine, HPV 16 E7:12-20 Peptide Vaccine and Laboratory Biomarker Analysis in people with Recurrent Melanoma and Stage IA Skin Melanoma, run by National Cancer Institute (NCI) at 1 site 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 12 inclusion and 4 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of positive CD8+ T cells (time frame: Up to 11 years). The study lists 2 primary outcomes in all. 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 NCT01989559.

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 26 Jan 2015.

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