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AzTrials

Intraocular MelanomaPhase 1NCT00471471

Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

A Phase 1 study testing Peptide vaccine, GM-CSF and PF3512676 in people with Intraocular Melanoma and Malignant Conjunctival Neoplasm, run by Ahmad Tarhini 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

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete Freund's adjuvant may make a stronger immune response and kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Peptide vaccine, GM-CSF and PF3512676
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Oct 2008to Dec 2011
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma meeting the following criteria:
  • Unresectable recurrent disease
  • Stage III or IV disease
  • Cutaneous, ocular, or mucosal melanoma
  • Measurable disease as defined by the RECIST criteria
  • HLA-A2 positive
  • Prior brain metastases allowed provided adequate surgical or radiologic treatment for brain disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1
  • WBC ≥ 3,000/mm³
  • Lymphocytes ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Lactic dehydrogenase ≤ 2.0 times ULN
  • aPTT < 40 seconds
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after completion of study therapy
  • No conditions of immunosuppression
  • Negative titers for antinuclear antibody (≤ 1/80) and antidouble stranded DNA (≤ 1/10)
  • No serious illnesses including, but not limited to, any of the following:
  • Bleeding disorders
  • Autoimmune diseases
  • Severe obstructive or restrictive pulmonary diseases
  • Active systemic infections
  • Inflammatory bowel disorders
  • No serious cardiovascular disease including, but not limited to, any of the following:
  • Uncontrolled congestive heart failure
  • Hypertension
  • Cardiac ischemia
  • Myocardial infarction,
  • Severe cardiac arrhythmia
  • HIV1 and 2 negative
  • HTLV-1 negative
  • Hepatitis B and C negative
  • No significant psychiatric disease, medical intervention, or other condition that, in the opinion of the principal investigator, would limit study compliance
  • No active infection within the past week, including unexplained fever (temperature > 38.1°C)

PRIOR CONCURRENT THERAPY:

  • Fully recovered from prior major surgery
  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas), hormonal therapy, radiotherapy, or biological therapy
  • More than 1 week since prior antibiotics
  • More than 28 days since prior investigational agent
  • No prior vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides alone or in combination
  • Patients with history of vaccination with peptides other than MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides allowed
  • More than 4 weeks since prior and no concurrent systemic immunosuppressive therapy, including steroids
  • Patients on maintenance steroids given at physiologic doses because of adrenal insufficiency are eligible
  • More than 2 weeks since prior and no concurrent treatment with systemic steroids, including oral steroids, continuous use of topical steroid creams or ointments, or any inhaled steroids
  • No concurrent anticoagulants, except to keep an indwelling line patent
  • No other concurrent anticancer therapy, including chemotherapy, immunotherapy, radiotherapy, experimental programs, and/or surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Safety and Immunogenicity of Vaccination With Multi-Epitope Peptide Vaccine Containing MART-1, gp100, and Tyrosinase Peptides Given With the Combination of GMCSF and CpG Oligonucleotide (CpG 7909) in ISA-Oil Adjuvant for Patients With Recurrent Inoperable Stage III or Stage IV Melanoma

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete Freund's adjuvant may make a stronger immune response and kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

  • Determine the safety of a peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in incomplete Freund's adjuvant in patients with unresectable recurrent stage III or IV melanoma.
  • Determine the efficacy of immunoadjuvants CpG 7909 and GM-CSF, in terms of a strong antigen-specific CD8+ T-cell response, in these patients.
  • Determine the anti-pigmentary response to this regimen in these patients.
  • Determine the anti-tumor response, in terms of objective tumor regression, progression-free survival, and overall survival, in patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in incomplete Freund's adjuvant subcutaneously on days 1 and 15. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, day 50-53, and day 91-94. Samples are examined by ELISPOT assay to measure lymphocyte immune response and by flow cytometry for biomarker quantification and T-cell response.

After completion of study treatment, patients are followed up periodically for at least 2 years.

Being tested
Peptide vaccine, GM-CSF, PF3512676
Keywords
recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma, conjunctival melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC 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.

  • Peptide vaccineBiological

    Multi-epitope peptide vaccine containing MART-1 (26-35, 27L), gp100 (209-217, 210M) and tyrosinase (368-376, 370D) peptides

  • GM-CSFBiological

    Also called Sargramostim

    80 mcg/0.16 mL using lyophilized 500 mcg/vial reconstituted with 1 mL of sterile water given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).

  • PF3512676Biological

    Also called CpG 7909, agatolimod

    0.6 mg/0.04 mL given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).

Study groups in NCT00471471
Study groupRoleWhat they receive
Peptide Vaccine + GM-CSF + Pfizer 3512676 in-ISA OilExperimentalThe water-in-oil emulsion will consist of peptide (100 mcg/0.1 mL), GM-CSF (80 mcg/0.16 mL using lyophilized 500 mcg/vial reconstituted with 1 mL of sterile water), Pfizer PF3512676 (0.6 mg/0.04 mL using 15mg/mL vial) and 0.20 mLl of sterile saline. Vaccination will be given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).
Receives: Biological: Peptide vaccine; Biological: GM-CSF; Biological: PF3512676

What is being measured

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

  1. Safety

    Number of grade 2 or greater allergic reactions (including generalized urticaria) or any grade 3 or greater adverse event

    Measured: up to 1 year

Secondary outcomes (3)

  1. Immunologic response

    Change in the circulating effector T-cells.

    Measured: up to 94 days

  2. Objective tumor regression

    Change in tumor size will be performed at the end of cycle 2.

    Measured: 2 months

  3. Depigmentation evaluation

    Change in cutaneous depigmentation using careful inspection of the skin of the torso by a Wood's lamp.

    Measured: up to 2 years

Timeline

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

  1. First posted10 May 2007 (estimated)
  2. Study startOct 2008
  3. Primary completionDec 2011
  4. Study completionDec 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00471471
Sponsor's protocol ID
04-173
Other IDs
NCI-2009-00159, PCI-IRB-0607048, CDR0000544402
Status last verified
Jun 2017
First submitted
8 May 2007
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Tarhini AA, Leng S, Moschos SJ, Yin Y, Sander C, Lin Y, Gooding WE, Kirkwood JM. Safety and immunogenicity of vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) in adjuvant with PF-3512676 and GM-CSF in metastatic melanoma. J Immunother. 2012 May;35(4):359-66. doi: 10.1097/CJI.0b013e31825481fe.

    PubMed 22495394

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Peptide vaccine, GM-CSF and PF3512676 in people with Intraocular Melanoma and Malignant Conjunctival Neoplasm, run by Ahmad Tarhini 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 22 Jun 2017. 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?

Safety (time frame: up to 1 year). 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 NCT00471471, 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 22 Jun 2017.

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