Intraocular MelanomaPhase 2NCT00334776
Vaccine Therapy in Treating Patients With Metastatic Melanoma
A Phase 2 study testing MART-1 antigen, gp100:209-217(210M) peptide vaccine and therapeutic autologous dendritic cells in people with Intraocular Melanoma and Melanoma (Skin), run by University of Southern California at 2 sites in United States.
Trial summary
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Intraocular Melanoma, Melanoma (Skin)
- What is being tested?
- MART-1 antigen, gp100:209-217(210M) peptide vaccine and therapeutic autologous dendritic cells
- Type of treatment
- Vaccines
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to Jun 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of melanoma
- Metastatic disease
- The following melanoma subtypes are eligible:
- Unresectable, stage III-IV uveal melanoma
- Metastatic mucosal melanoma
- Measurable disease after attempted curative surgical therapy
- Tumor tissue must be available for immunohistochemical staining
- Positive for ≥ 1 of the following peptides:
- MART-1: 26-35 (27L)
- gp100: 209-217 (210M)
- Tyrosinase: 368-376 (370D)
- HLA-A *0201 positive by DNA polymerase chain reaction assay
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.0 mg/dL
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- No major systemic infections
- No coagulation disorders
- No major medical illness of the cardiovascular or respiratory system
- No myocardial infarction within the past 6 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No know positivity for hepatitis B surface antigen or hepatitis C antibody
- No prior uveitis or autoimmune inflammatory eye disease
- No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior cytotoxic chemotherapy agent or regimen
- Prior biologic or antiangiogenic therapies allowed
- More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
- No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
- No concurrent steroid therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
About this study
Official title: A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.
Secondary
- Determine immunologic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically until disease progression.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Being tested
- MART-1 antigen, gp100:209-217(210M) peptide vaccine, therapeutic autologous dendritic cells, tyrosinase peptide
- Keywords
- recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, iris melanoma, recurrent intraocular melanoma, extraocular extension 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
gp100:209-217(210M) peptide vaccineBiological
therapeutic autologous dendritic cellsBiological
tyrosinase peptideBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Progression-free survival
Time to progression
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startOct 2003
- Primary completionJun 2005
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT00334776
- Sponsor's protocol ID
- 10M-03-1
- Other IDs
- LAC-USC-10M-03-1, NCI-6262, LAC-USC-033307, CDR0000480137, NCI-2009-00050
- Status last verified
- May 2014
- First submitted
- 7 Jun 2006
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00334776
- Acronym / sponsor ID
- 10M-03-1
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, iris melanoma, recurrent intraocular melanoma, extraocular extension melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 8 Jun 2006 (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: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.
Secondary
- Determine immunologic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically until disease progression.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- 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 | – |
| gp100:209-217(210M) peptide vaccine | Biological | – |
| therapeutic autologous dendritic cells | Biological | – |
| tyrosinase peptide | Biological | – |
Primary outcome
Overall survival
Progression-free survival
Time to progression
Toxicity
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 21 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MART-1 antigen, gp100:209-217(210M) peptide vaccine and therapeutic autologous dendritic cells in people with Intraocular Melanoma and Melanoma (Skin), run by University of Southern California at 2 sites 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 21 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 2 sites 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.
What does the primary outcome measure?
Overall survival. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 21 May 2014.