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Intraocular MelanomaPhase 1NCT00025181

Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery

A Phase 1 study testing MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant in people with Intraocular Melanoma and Melanoma (Skin), run by University of Southern California 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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Read more about this study

Who is it for?
Any age
Conditions the study is for
Intraocular Melanoma, Melanoma (Skin)
What is being tested?
MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant
Type of treatment
Surgery or procedure
How many people
19 participants
Where
1 siteUnited States
Study dates
Oct 2001to Jun 2005
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed completely resected stage III or IV melanoma
  • Mucosal or ocular subtypes allowed
  • HLA-A2 positive
  • Positive staining of tumor tissue with antibody HMB-45 for gp100, tyrosinase, and/or MART-1
  • Failed (or ineligible for or refusal of) interferon alfa

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 12 months

Hematopoietic:

  • WBC at least 2,500/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Hematocrit at least 30%

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 1.25 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody nonreactive

Renal:

  • Creatinine less than 1.25 times ULN

Immunologic:

  • Antinuclear antibody (ANA) negative OR
  • If ANA positive, must be:
  • Antithyroglobulin antibody negative
  • Rheumatoid factor negative
  • Anti-LKM antibody negative
  • Anti-phospholipid antibody negative
  • Anti-islet cell antibody negative
  • Anti-neutrophil cytoplasmic antibody negative
  • HIV negative
  • No autoimmune disease (e.g., uveitis or autoimmune inflammatory eye disease)
  • No active infection
  • No hypersensitivity to tyrosinase:368-376, gp100:209-217, MART-1:26-35, or Montanide ISA-51

Other:

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  • No underlying medical condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • No prior tyrosinase, gp100, or MART-1 peptide
  • No prior antitumor vaccination
  • No prior interleukin-2
  • At least 4 weeks since prior immunotherapy for melanoma

Chemotherapy:

  • At least 4 weeks since prior chemotherapy for melanoma

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy for melanoma
  • At least 4 weeks since prior corticosteroids
  • No concurrent systemic or topical corticosteroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy for melanoma

Surgery:

  • See Disease Characteristics

Other:

  • No prior cytotoxic therapy
  • At least 4 weeks since any other prior therapy for melanoma
  • Concurrent analgesics allowed if on stable dose for at least 2 weeks before study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089

Other trials in United States

About this study

Official title: An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery.

Read the detailed description

OBJECTIVES:

  • Determine the safety and adverse event profile of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 in patients with resected stage III or IV melanoma.
  • Determine if this regimen causes antigen-specific T-cell activation in these patients.
  • Determine the clearance profile of this regimen in these patients.
  • Assess the development of host immune response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4).

Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4, 5, 8, and 11 months in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Being tested
MART-1 antigen, gp100 antigen, incomplete Freund's adjuvant, ipilimumab, tyrosinase peptide
Keywords
iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent 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.

  • MART-1 antigenBiological

  • gp100 antigenBiological

  • incomplete Freund's adjuvantBiological

  • ipilimumabBiological

  • tyrosinase peptideBiological

  • adjuvant therapyProcedure or surgery

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001
  3. Primary completionJan 2003
  4. Study completionJun 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 1
Primary purpose
Treatment
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025181
Sponsor's protocol ID
CDR0000068934 (10M-00-4)
Other IDs
LAC-USC-10M004, MDX-MDXCTLA4-03, NCI-4210
Status last verified
May 2014
First submitted
11 Oct 2001
Last updated
22 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant in people with Intraocular Melanoma and Melanoma (Skin), run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 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 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.

Where can I read the original study information?
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 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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