Melanoma (Skin)Phase 2NCT00006113
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase 2 study testing MART-1 antigen, aldesleukin and gp100 antigen in people with Melanoma (Skin), run by University of Southern California at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- MART-1 antigen, aldesleukin and gp100 antigen
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Apr 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma
- Measurable disease after attempted curative surgery
- Unresectable stage III or IV uveal melanoma
- Metastatic mucosal melanoma
- HLA-A2.1 positive
- No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 75,000/mm^3
- Hemoglobin at least 9.0 g/dL
- No coagulation disorders
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- Patients with documented or suspected coronary artery disease must undergo stress thallium test
- No major cardiovascular illness
Pulmonary:
- No major pulmonary illness
Immunologic:
- HIV negative
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- No history of uveitis or autoimmune inflammatory eye disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No major systemic infection
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens
Chemotherapy:
- At least 1 month since prior chemotherapy for melanoma
Endocrine therapy:
- No concurrent steroid therapy
Radiotherapy:
- At least 1 month since prior radiotherapy for melanoma
Surgery:
- See Disease Characteristics
Other:
- At least 1 month since prior adjuvant therapy for melanoma
- At least 1 month since other prior therapy for melanoma
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: A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.
Read the detailed description
OBJECTIVES:
- Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.
- Conditions
- Melanoma (Skin)
- Being tested
- MART-1 antigen, aldesleukin, gp100 antigen, recombinant CD40-ligand, recombinant interferon gamma
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MART-1 antigenBiological
aldesleukinBiological
gp100 antigenBiological
recombinant CD40-ligandBiological
recombinant interferon gammaBiological
recombinant interleukin-4Biological
sargramostimBiological
therapeutic autologous dendritic cellsBiological
therapeutic tumor infiltrating lymphocytesBiological
tyrosinase peptideBiological
Candida albicans skin test reagentRadiation
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 startJun 1999
- Primary completionMay 2003
- Study completionApr 2006
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies 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
- Enrolment
- 25 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
- NCT00006113
- Sponsor's protocol ID
- CDR0000068125 (10M-99-1)
- Other IDs
- LAC-USC-10M991, NCI-G00-1837, NCI-T99-0102
- Status last verified
- May 2014
- First submitted
- 3 Aug 2000
- 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
- A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00006113
- Acronym / sponsor ID
- CDR0000068125 (10M-99-1)
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1999
- Primary completion
- May 2003 (actual)
- Study completion
- Apr 2006 (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: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.
Detailed description
OBJECTIVES:
- Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 | – |
| aldesleukin | Biological | – |
| gp100 antigen | Biological | – |
| recombinant CD40-ligand | Biological | – |
| recombinant interferon gamma | Biological | – |
| recombinant interleukin-4 | Biological | – |
| sargramostim | Biological | – |
| therapeutic autologous dendritic cells | Biological | – |
| therapeutic tumor infiltrating lymphocytes | Biological | – |
| tyrosinase peptide | Biological | – |
| Candida albicans skin test reagent | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
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 2 study testing MART-1 antigen, aldesleukin and gp100 antigen in people with 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.
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: stopped early, 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 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 was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
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.