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Intraocular MelanomaPhase 2NCT00089206

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

A Phase 2 study testing incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine and sargramostim 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
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Trial summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Intraocular Melanoma, Melanoma (Skin)
What is being tested?
incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine and sargramostim
Type of treatment
Vaccines
How many people
7 participants
Where
1 siteUnited States
Study dates
Aug 2002to Nov 2005
Phase
Phase 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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma
  • Unresectable stage III or IV disease
  • Mucosal or ocular disease allowed
  • Positive HLA-A1, -A2, or -A3 expression

PATIENT CHARACTERISTICS:

Age

  • 12 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

  • Weight ≥ 100 pounds
  • Not pregnant or nursing
  • No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior vaccination with any of the peptides used in this protocol
  • More than 1 year since prior melanoma vaccine therapy
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior growth factors
  • More than 4 weeks since prior allergy shots

Chemotherapy

  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior steroid therapy

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • Prior tumor resection allowed

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma

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

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

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

OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.

PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Being tested
incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine, sargramostim
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma, recurrent intraocular melanoma, iris melanoma, extraocular extension melanoma, ciliary body and choroid melanoma, medium/large size
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.

  • incomplete Freund's adjuvantBiological

  • multi-epitope melanoma peptide vaccineBiological

  • sargramostimBiological

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 startAug 2002
  3. Primary completionNov 2005

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089206
Sponsor's protocol ID
10049
Other IDs
UVACC-MEL-42, UVACC-24802
Status last verified
Dec 2014
First submitted
4 Aug 2004
Last updated
19 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine and sargramostim 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 19 Dec 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 phase mean?

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00089206.

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 19 Dec 2014.

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