MelanomaPhase 1NCT00028431
Novel Adjuvants for Peptide-Based Melanoma Vaccines
A Phase 1 study testing MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine in people with Melanoma, run by University of Southern California at 1 site in United States.
Trial summary
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine
- Type of treatment
- Vaccines
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma
- Completely resected disease or disease-free
- HLA-A2.1 positive
- Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens
- At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy
- WBC count at least 3,000/mm3
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- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9.0 gm/dL
- Creatinine no greater than 2.0 mg/dL
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 2.5 times upper limit of normal
- ECOG performance status 0-1
- Have failed alpha-interferons (patients with resected stage III disease)
Who cannot join
- Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides
- Steroid therapy or other immunosuppressive medication requirement
- Major systemic infections (e.g., pneumonia or sepsis)
- Coagulation or bleeding disorders
- Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems
- Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant)
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- History of uveitis or autoimmune inflammatory eye disease
- Other active autoimmune disease
- Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center
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 IV Melanoma
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.
Read the detailed description
In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.
- Conditions
- Melanoma
- Being tested
- MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine
- Keywords
- Stage III melanoma, Stage IV melanoma, Interleukin-12, Cancer Vaccines, Antineoplastic Agents, Combined, Incomplete Freund's adjuvant, Monophenol Monooxygenase, Mannitol, Adjuvants, Immunologic, Melan-A Protein, Antigens, Neoplasm, Antibodies, Melanocyte lineage-specific antigen gp100, CTLA-4
- Medical subject headings
- Melanoma, Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma VaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2002 (estimated)
- Study startAug 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 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey S. Weber, M.D., Ph.D., Principal investigator, University of Southern California/Norris Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028431
- Sponsor's protocol ID
- FD-R-1975-01
- Other IDs
- 10M-00-4;, FD-R-001975-01
- Status last verified
- May 2014
- First submitted
- 4 Jan 2002
- Last updated
- 22 May 2014
- Results posted
- No
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 IV Melanoma
- ClinicalTrials.gov ID
- NCT00028431
- Acronym / sponsor ID
- FD-R-1975-01
- Conditions
- Melanoma
- Keywords
- Stage III melanoma, Stage IV melanoma, Interleukin-12, Cancer Vaccines, Antineoplastic Agents, Combined, Incomplete Freund's adjuvant, Monophenol Monooxygenase, Mannitol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 9 Jan 2002 (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.
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.
Detailed description
In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma
- Completely resected disease or disease-free
- HLA-A2.1 positive
- Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens
- At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy
Key exclusion criteria (10 listed)
- Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides
- Steroid therapy or other immunosuppressive medication requirement
- Major systemic infections (e.g., pneumonia or sepsis)
- Coagulation or bleeding disorders
- Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems
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 |
|---|---|---|
| MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine | Biological | – |
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, M.D., Ph.D. principal investigator
University of Southern California/Norris Cancer Center
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 MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine in people with Melanoma, 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?
The sponsor lists 14 inclusion and 10 exclusion criteria. 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 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.