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.
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
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.
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- 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.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
- Primary completionJan 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular MelanomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey S. Weber, MD, PhD, Study chair, University of Southern California
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00025181
- Acronym / sponsor ID
- CDR0000068934 (10M-00-4)
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2001
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MART-1 antigen | Biological | – |
| gp100 antigen | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
| ipilimumab | Biological | – |
| tyrosinase peptide | Biological | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S. Weber, MD, PhD study chair
University of Southern California
1 site in 1 country: see every site and its status.
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.