Melanoma (Skin)Phase 2NCT00077532
Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma
A Phase 2 study testing gp100 antigen, incomplete Freund's adjuvant and ipilimumab in people with Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- gp100 antigen, incomplete Freund's adjuvant and ipilimumab
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Feb 2008
- 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:
- Histologically confirmed stage IV melanoma
- Clinically evaluable or measurable disease
- No mucosal or ocular melanoma
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Hematocrit ≥ 28%
- WBC ≥ 2,500/mm^3
Hepatic
- AST ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ ULN (< 3 mg/dL for patients with Gilbert's syndrome)
- Hepatitis B surface antigen negative
- Hepatitis C virus antibody negative
Renal
- Creatinine < 2 mg/dL
Immunologic
- HIV negative
- No history of any of the following:
- Inflammatory bowel disease
- Regional enteritis
- Connective tissue disorders (e.g., systemic lupus erythematosus)
- Rheumatoid arthritis
- Autoimmune inflammatory eye disease
- Sjögren's syndrome
- Inflammatory neurologic disorder (e.g., multiple sclerosis)
- No active infection
- No active autoimmune disease that may cause life-threatening symptoms or severe organ/tissue damage
- Vitiligo, autoimmune thyroiditis, or skin rashes associated with prior therapy are allowed if patient has recovered to grade 1 or less toxicity
- No systemic hypersensitivity to study agents
- Prior local reaction (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 or gp100 injections allowed
- No autoimmune disease requiring active therapy with any form of steroid or immunosuppressant
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent underlying medical condition that would preclude study participation
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
- Prior therapy with gp100 peptides or any other immunotherapy allowed
Chemotherapy
- At least 6 weeks since prior nitrosoureas and recovered (toxicity no greater than grade 1)
- No concurrent chemotherapy
Endocrine therapy
- At least 4 weeks since prior steroids
- No concurrent systemic, inhaled, optical, or topical corticosteroids
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 3 weeks since prior systemic therapy for melanoma and recovered (toxicity no greater than grade 1)
- No concurrent immunosuppressive agents (e.g., cyclosporine)
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: A Study of Intra-Patient Escalating Doses of MDX-010 Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 in the Treatment of Patients With Stage IV Melanoma
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma.
PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the clinical response in patients with stage IV melanoma treated with escalating doses of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) with or without gp100 peptides emulsified in Montanide ISA-51.
Secondary
- Determine the safety and toxicity profile of these regimens in these patients.
- Determine the immunologic response in patients treated with these regimens.
- Determine the pharmacokinetics of these regimens in these patients.
- Determine, in HLA-A*0201-positive patients, the differences in responses between patients previously vaccinated with gp100 peptides and patients not previously vaccinated.
OUTLINE: This is a 2-part, partially randomized study.
- Part I (closed as of 3/7/2005):
- HLA-A*0201-negative patients: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 doses (3 courses of 3 escalating doses) in the absence of disease progression or unacceptable toxicity.
- HLA-A*0201-positive patients: Patients are stratified according to prior exogenous gp100 peptide immunization (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive MDX-010 in the same manner as the HLA-A*0201-negative patients.
- Arm II: Patients receive MDX-010 as in arm I. Patients also receive gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion.
- Part II:
- HLA-A*0201-negative patients (closed as of 3/7/2005): Patients receive MDX-010 as in part I. Treatment repeats every 3 weeks for up to 4 doses (2 courses of 2 escalating doses, beginning with a higher dose level than in part I) in the absence of disease progression or unacceptable toxicity.
- HLA-A*0201-positive patients: Patients are stratified and randomized as in part I.
- Arm I: Patients receive MDX-010 in the same manner as the HLA-A*0201-negative patients.
- Arm II: Patients receive MDX-010 as in arm I. Patients also receive gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion.
In both parts, patients with stable disease or a complete response (CR) after completing all courses of MDX-010 may receive 1 additional course of therapy in the absence of unacceptable toxicity. Patients achieving a partial response may continue to recieve treatment with MDX-010 at the same dose, in the absence of unacceptable toxicity, until CR or until tumor is no longer shrinking.
Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 35-179 patients (up to 35 for part I [closed as of 3/7/05] and 69-141 [23-47 per arm (arm I closed as of 3/7/05)] for part II) will be accrued for this study within 3-4 years.
- Conditions
- Melanoma (Skin)
- Being tested
- gp100 antigen, incomplete Freund's adjuvant, ipilimumab
- Keywords
- 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.
gp100 antigenBiological
incomplete Freund's adjuvantBiological
ipilimumabBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response (partial and complete)
Secondary outcomes (2)
Safety
Immune response activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startMar 2004
- Primary completionJan 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- 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
- Randomised
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven A. Rosenberg, MD, PhD, Principal investigator, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077532
- Sponsor's protocol ID
- 040083
- Other IDs
- 04-C-0083, MDX-010-19, NCI-6532, CDR0000352187
- Status last verified
- Jun 2012
- First submitted
- 10 Feb 2004
- Last updated
- 22 Jun 2012
- Results posted
- No
Publications
Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
PubMed 25667295
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Intra-Patient Escalating Doses of MDX-010 Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 in the Treatment of Patients With Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00077532
- Acronym / sponsor ID
- 040083
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 12 Feb 2004 (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: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma.
PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the clinical response in patients with stage IV melanoma treated with escalating doses of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) with or without gp100 peptides emulsified in Montanide ISA-51.
Secondary
- Determine the safety and toxicity profile of these regimens in these patients.
- Determine the immunologic response in patients treated with these regimens.
- Determine the pharmacokinetics of these regimens in these patients.
- Determine, in HLA-A*0201-positive patients, the differences in responses between patients previously vaccinated with gp100 peptides and patients not previously vaccinated.
OUTLINE: This is a 2-part, partially randomized study.
- Part I (closed as of 3/7/2005):
- HLA-A*0201-negative patients: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 doses (3 courses of 3 escalating doses) in the absence of disease progression or unacceptable toxicity.
- HLA-A*0201-positive patients: Patients are stratified according to prior exogenous gp100 peptide immunization (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive MDX-010 in the same manner as the HLA-A*0201-negative patients.
- Arm II: Patients receive MDX-010 as in arm I. Patients also receive gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion.
- Part II:
- HLA-A*0201-negative patients (closed as of 3/7/2005): Patients receive MDX-010 as in part I. Treatment repeats every 3 weeks for up to 4 doses (2 courses of 2 escalating doses, beginning with a higher dose level than in part I) in the absence of disease progression or unacceptable toxicity.
- HLA-A*0201-positive patients: Patients are stratified and randomized as in part I.
- Arm I: Patients receive MDX-010 in the same manner as the HLA-A*0201-negative patients.
- Arm II: Patients receive MDX-010 as in arm I. Patients also receive gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion.
In both parts, patients with stable disease or a complete response (CR) after completing all courses of MDX-010 may receive 1 additional course of therapy in the absence of unacceptable toxicity. Patients achieving a partial response may continue to recieve treatment with MDX-010 at the same dose, in the absence of unacceptable toxicity, until CR or until tumor is no longer shrinking.
Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 35-179 patients (up to 35 for part I [closed as of 3/7/05] and 69-141 [23-47 per arm (arm I closed as of 3/7/05)] for part II) will be accrued for this study within 3-4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| gp100 antigen | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
| ipilimumab | Biological | – |
Primary outcome
Objective response (partial and complete)
2 secondary outcomes
Safety
Immune response activity
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 Jun 2012.
- Derived from this study: PubMed 25667295Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
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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.
Steven A. Rosenberg, MD, PhD principal investigator
NCI - Surgery Branch
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 gp100 antigen, incomplete Freund's adjuvant and ipilimumab in people with Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) 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: finished, as of the sponsor's last update on 22 Jun 2012. 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 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?
Objective response (partial and complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00077532, which also lists 1 linked publication.
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 Jun 2012.