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Recurrent MelanomaNCT00006243

Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma

A study testing tyrosinase peptide, MART-1:27-35 peptide vaccine and gp100 antigen in people with Recurrent Melanoma and Stage IV 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 randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
tyrosinase peptide, MART-1:27-35 peptide vaccine and gp100 antigen
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Oct 2000to May 2006
Phase
Interventional
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

Who may be able to join

  • Human leukocyte antigen (HLA)-A2 positive
  • Histologic proof of stage IV malignant melanoma with measurable disease
  • Absolute neutrophil count (ANC) >= 1500
  • Platelets (PLT) >= 100,000
  • Alkaline phosphatase (Alk phos) =< 3 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =< 3 x ULN
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  • Creatinine (Creat) =< 1.5 x ULN
  • Hemoglobin (Hgb) > 9.0
  • Ability to provide informed consent
  • Willingness to return to a Mayo Clinic institution for follow-up
  • Life expectancy >= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Who cannot join

  • Uncontrolled or current infection
  • Prior immunization with differentiation antigen peptides
  • Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
  • Any of the following prior therapies:
  • Chemotherapy =< 4 weeks
  • Mitomycin C/nitrosoureas =< 6 weeks
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  • Immunotherapy =<4 weeks
  • Biologic therapy =< 4 weeks
  • Radiation therapy =< 4 weeks
  • Radiation to > 25% of bone marrow
  • Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment
  • New York Heart Association classification III or IV
  • Seizure disorder
  • Any of the following:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • Other concurrent chemotherapy, immunotherapy, or radiotherapy
  • Active psychiatric disorder requiring medications (anti-psychotics)
  • Known central nervous system metastases or carcinomatous meningitis
  • History of other malignancy in last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only (it is impossible to predict the effect of study treatment on other, potentially dormant malignant diseases)
  • Known immune deficiency (patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Melanoma Vaccines: Differentiation Antigen Peptides (MART-1:27-35, Tyrosinase and Gp-100) as Immune Targets

This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the immunological effects of immunization protocols utilizing MART-1:27-35 (MART-1:27-35 peptide vaccine), tyrosinase (tyrosinase peptide) or gp-100 (gp100 antigen) peptides suspended in incomplete Freund's adjuvant (IFA) in the presence of two different concentrations of sargramostim (GM-CSF).

II. Define the safety and toxicity profile of an immunization protocol utilizing varying concentrations of MART-1:27-35, tyrosinase and gp-100 peptides suspended in IFA in the presence of two different concentrations of GM-CSF.

III. Collect preliminary data on therapeutic efficacy as it relates to parameters of immune function in patients with stage IV malignant melanoma.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant subcutaneously (SC) on day 1 of weeks 0, 3, 6, 9, 12, and 24.

ARM II: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.

ARM III: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.

In all arms, treatment may repeat every 3 months for up to 18 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Being tested
tyrosinase peptide, MART-1:27-35 peptide vaccine, gp100 antigen, incomplete Freund's adjuvant, sargramostim
Medical subject headings
Melanoma

What participants receive

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

  • tyrosinase peptideBiological

    Also called TYRP

    Given SC

  • MART-1:27-35 peptide vaccineBiological

    Given SC

  • gp100 antigenBiological

    Also called gp100

    Given SC

  • incomplete Freund's adjuvantBiological

    Also called IFA, ISA-51, Montanide ISA 51

    Given SC

  • sargramostimBiological

    Also called GM-CSF, Leukine, Prokine

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00006243
Study groupRoleWhat they receive
Arm I (vaccine therapy)ExperimentalPatients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
Receives: Biological: tyrosinase peptide; Biological: MART-1:27-35 peptide vaccine; Biological: gp100 antigen; Biological: incomplete Freund's adjuvant; Other: laboratory biomarker analysis
Arm II (vaccine therapy and lower-dose sargramostim)ExperimentalPatients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
Receives: Biological: tyrosinase peptide; Biological: MART-1:27-35 peptide vaccine; Biological: gp100 antigen; Biological: incomplete Freund's adjuvant; Biological: sargramostim; Other: laboratory biomarker analysis
Arm III (vaccine therapy and higher-dose sargramostim)ExperimentalPatients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
Receives: Biological: tyrosinase peptide; Biological: MART-1:27-35 peptide vaccine; Biological: gp100 antigen; Biological: incomplete Freund's adjuvant; Biological: sargramostim; Other: laboratory biomarker analysis

What is being measured

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

  1. Changes in tumor antigen peptide specific immune responses

    Plots of the percent changes in these factors from their pretreatment levels against time will be constructed.

    Measured: Baseline and 24 weeks

Secondary outcomes (2)

  1. Number and severity of hematologic and non-hematologic toxicities observed using the Common Toxicity Criteria (CTC) version 2.0

    Measured: Up to 3 years

  2. Proportion of objective responses (complete response [CR] and partial response [PR]) observed

    Measured: Up to 3 years

Timeline

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

  1. First posted22 May 2003 (estimated)
  2. Study startOct 2000
  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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006243
Sponsor's protocol ID
NCI-2012-02359
Other IDs
MC9973, CDR0000068171
Status last verified
Jan 2013
First submitted
11 Sep 2000
Last updated
25 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing tyrosinase peptide, MART-1:27-35 peptide vaccine and gp100 antigen in people with Recurrent Melanoma and Stage IV 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 22 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 25 Jan 2013. 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.

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?

Changes in tumor antigen peptide specific immune responses (time frame: Baseline and 24 weeks). 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 NCT00006243.

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 25 Jan 2013.

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