AzTrials
AzTrials

Intraocular MelanomaPhase 1/2NCT00089219

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

A Phase 1/2 study testing IFA, 6MHP and GM-CSF in people with Intraocular Melanoma and Melanoma (Skin), run by University of Virginia 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
Search all trials

Trial summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intraocular Melanoma, Melanoma (Skin)
What is being tested?
IFA, 6MHP and GM-CSF
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Jul 2003to May 2006
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of stage IIIB, IIIC, or IV melanoma
  • HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
  • Brain metastases allowed at the discretion of the principle investigator

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm ^3
  • Hemoglobin > 9 g/dL

Hepatic

  • Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Other

  • Prior diagnosis of other cancer allowed
  • Not pregnant or nursing
  • Weight ≥ 110 pounds
  • No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior growth factors
  • More than 4 weeks since prior allergy shots
  • More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
  • No prior vaccination with any of the peptides used in this study

Chemotherapy

  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior steroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • More than 1 month since prior investigational drugs or therapies
  • No other concurrent investigational drugs or therapies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

Read the detailed description

OBJECTIVES:

  • Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
  • Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
  • Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Being tested
IFA, 6MHP, GM-CSF
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma
Medical subject headings
Uveal Melanoma, Melanoma

What participants receive

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

  • IFABiological

    Also called incomplete Freund's adjuvant, Montanide ISA-51

    vaccine adjuvant

  • 6MHPBiological

    Also called multi-epitope melanoma peptide vaccine

    melanoma helper peptides

  • GM-CSFBiological

    Also called sargramostim

    vaccine adjuvant

Study groups in NCT00089219
Study groupRoleWhat they receive
Arm A. 6MHP vaccine 200 mcgExperimentalvaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Receives: Biological: IFA; Biological: 6MHP; Biological: GM-CSF
Arm B. 6MHP vaccine 400 mcgExperimentalvaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Receives: Biological: IFA; Biological: 6MHP; Biological: GM-CSF
Arm C. 6MHP vaccine 800 mcgExperimentalvaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Receives: Biological: IFA; Biological: 6MHP; Biological: GM-CSF

What is being measured

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

  1. Safety: Dose-limiting toxicity

    Toxicities measured by CTCAE.

    Measured: During study period

  2. Immunogenicity

    Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.

    Measured: day 22

Secondary outcomes (3)

  1. Immune response in the blood

    Immune response measured in the blood, by proliferation assay, over time during the study.

    Measured: day 50

  2. DTH response

    Delayed-type hypersensitivity response to tumor peptides

    Measured: by day 85

  3. Clinical outcome

    Clinical tumor response

    Measured: during the study

Timeline

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

  1. First posted5 Aug 2004 (estimated)
  2. Study startJul 2003
  3. Primary completionMay 2006

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089219
Sponsor's protocol ID
10464
Other IDs
UVACC-MEL-41, UVACC-28502
Status last verified
Nov 2014
First submitted
4 Aug 2004
Last updated
20 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Slingluff CL Jr, Petroni GR, Olson W, Czarkowski A, Grosh WW, Smolkin M, Chianese-Bullock KA, Neese PY, Deacon DH, Nail C, Merrill P, Fink R, Patterson JW, Rehm PK. Helper T-cell responses and clinical activity of a melanoma vaccine with multiple peptides from MAGE and melanocytic differentiation antigens. J Clin Oncol. 2008 Oct 20;26(30):4973-80. doi: 10.1200/JCO.2008.17.3161. Epub 2008 Sep 22.

    PubMed 18809608

  • Shukla GS, Olson WC, Pero SC, Sun YJ, Carman CL, Slingluff CL Jr, Krag DN. Vaccine-draining lymph nodes of cancer patients for generating anti-cancer antibodies. J Transl Med. 2017 Aug 29;15(1):180. doi: 10.1186/s12967-017-1283-8.

    PubMed 28851380

  • Dillon PM, Olson WC, Czarkowski A, Petroni GR, Smolkin M, Grosh WW, Chianese-Bullock KA, Deacon DH, Slingluff CL Jr. A melanoma helper peptide vaccine increases Th1 cytokine production by leukocytes in peripheral blood and immunized lymph nodes. J Immunother Cancer. 2014 Jul 15;2:23. doi: 10.1186/2051-1426-2-23. eCollection 2014.

    PubMed 25126421

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IFA, 6MHP and GM-CSF in people with Intraocular Melanoma and Melanoma (Skin), run by University of Virginia 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?

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 2014. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Safety: Dose-limiting toxicity (time frame: During study period). 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 NCT00089219, which also lists 3 linked publications.

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 2014.

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