Melanoma (Skin)Phase 1NCT00003224
Vaccine Therapy in Treating Patients With Metastatic Melanoma
A Phase 1 study testing QS21, IFA (incomplete Freund's adjuvant) and p946 in people with Melanoma (Skin), run by University of Virginia at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- QS21, IFA (incomplete Freund's adjuvant) and p946
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1996to Aug 2000
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above)
- Age: 18 to 79
- Performance status: ECOG 0-2
- Life expectancy: Greater than 12 months
- Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL
- Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN
- Renal: Creatinine no greater than 1.5 times ULN
Who cannot join
- patients currently receiving cytotoxic chemotherapy or who have received that therapy within the preceding 3 months
- known or suspected allergies to any component of the treatment vaccine
- unresectable tumor llikely to cause symptoms and for which therapy is anticipated within 3 months.
- receiving acute treatment for seriouis infection within 14 days.
- Patients with bulky disease, or with multiple brain metastases, but solitary brain metastases treated successfully with surgery or gamma knife may be eligible.
- Any of the following with 3 months:
Show all 15Show fewer
- agentes with putative immunomodulating activity (except NSAIDs)
- allergy desensitizing injections
- other investigational agents
- interferons
- corticosteroids
- any growth factors
- prior melanoma vaccinations
- pregnancy or the possibility of becoming pregnant on study
- medical contraindication or potential problems in complying with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
About this study
Official title: Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma
RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.
Read the detailed description
OBJECTIVES:
- Determine the safety of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.
II. Determine the immunogenicity of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 6 treatment arms: Arm I: Patients receive peptide 946 melanoma vaccine (peptide 946) emulsified with QS21 subcutaneously (SQ). Arm II: Patients receive peptide 946 emulsified with Montanide ISA-51 (ISA-51) SQ. Arm III: Patients receive peptide 946 combined with tetanus peptide melanoma vaccine (tetanus peptide) emulsified with QS21 SQ. Arm IV: Patients receive peptide 946 combined with tetanus peptide emulsified with ISA-51 SQ. Arm V: Patients receive peptide 946-tetanus peptide conjugate emulsified with QS21 SQ. Arm VI: Patients receive peptide 946-tetanus peptide conjugate emulsified with ISA-51 SQ. Initially, 4 patients are randomized to Arm I and 4 patients are randomized to Arm II. If no dose limiting toxicities are observed in these patients, then additional patients are randomized to arms III-VI. Patients in each arm receive vaccine on day 0 and at months 1, 2, 3, 6, 9, and 12. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- QS21, IFA (incomplete Freund's adjuvant), p946, p946/tet-p, Tet-p
- Keywords
- stage II melanoma, 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.
QS21Biological
vaccine adjuvant
IFA (incomplete Freund's adjuvant)Biological
Also called Montanide ISA-51, from Seppic.
Peptides emulsified in IFA.
p946Biological
Also called peptide 946, gp100 [280-288], YLEPGPVTA
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
p946/tet-pBiological
Also called peptide 946-tetanus peptide conjugate melanoma vaccine
This peptide is a longer version of p946 (gp100 [280-288]) sythesized colinearly with the tetanus helper peptide (Tet-p)
Tet-pBiological
Also called tetanus peptide melanoma vaccine
modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: peptide 946 plus QS-21 | Experimental | 100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant Receives: Biological: QS21; Biological: p946 |
| Group 2. p946 plus IFA | Experimental | 100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant Receives: Biological: IFA (incomplete Freund's adjuvant); Biological: p946 |
| Group 3: p946 plus Tet-p plus QS-21 | Experimental | 100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant Receives: Biological: QS21; Biological: p946; Biological: Tet-p |
| Group 4. p946, Tet-p plus IFA | Experimental | 100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant Receives: Biological: IFA (incomplete Freund's adjuvant); Biological: p946; Biological: Tet-p |
| Group 5: p946/Tet-p plus QS-21 | Experimental | 282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant Receives: Biological: QS21; Biological: p946/tet-p |
| Group 6. p946/Tet-p plus IFA | Experimental | 282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant Receives: Biological: IFA (incomplete Freund's adjuvant); Biological: p946/tet-p |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Grade 3 Adverse Events
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria
Measured: Up to 24 months after last vaccine
Secondary outcomes (1)
Immunogenicity of Each Vaccine Regimen
T cell responses to the p946 (gp100 [280-288]) peptide. All enrolled patients were assayed for immune response to the gp100 peptide by ELIspot assay after 14 days in vitro sensitization. The number with a response in each study arm is reported.
Measured: up to 12 months since enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2004 (estimated)
- Study startFeb 1996
- Primary completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L. Slingluff, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003224
- Sponsor's protocol ID
- 6346
- Other IDs
- NCI-H98-0010
- Status last verified
- Nov 2014
- First submitted
- 1 Nov 1999
- Last updated
- 20 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Slingluff CL Jr, Yamshchikov G, Neese P, Galavotti H, Eastham S, Engelhard VH, Kittlesen D, Deacon D, Hibbitts S, Grosh WW, Petroni G, Cohen R, Wiernasz C, Patterson JW, Conway BP, Ross WG. Phase I trial of a melanoma vaccine with gp100(280-288) peptide and tetanus helper peptide in adjuvant: immunologic and clinical outcomes. Clin Cancer Res. 2001 Oct;7(10):3012-24.
PubMed 11595689
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma
- ClinicalTrials.gov ID
- NCT00003224
- Acronym / sponsor ID
- 6346
- Conditions
- Melanoma (Skin)
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1996
- Primary completion
- Aug 2000 (actual)
- First posted
- 25 Aug 2004 (estimated)
- Results
- Posted 20 Nov 2014
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 peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.
Detailed description
OBJECTIVES:
- Determine the safety of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.
II. Determine the immunogenicity of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 6 treatment arms: Arm I: Patients receive peptide 946 melanoma vaccine (peptide 946) emulsified with QS21 subcutaneously (SQ). Arm II: Patients receive peptide 946 emulsified with Montanide ISA-51 (ISA-51) SQ. Arm III: Patients receive peptide 946 combined with tetanus peptide melanoma vaccine (tetanus peptide) emulsified with QS21 SQ. Arm IV: Patients receive peptide 946 combined with tetanus peptide emulsified with ISA-51 SQ. Arm V: Patients receive peptide 946-tetanus peptide conjugate emulsified with QS21 SQ. Arm VI: Patients receive peptide 946-tetanus peptide conjugate emulsified with ISA-51 SQ. Initially, 4 patients are randomized to Arm I and 4 patients are randomized to Arm II. If no dose limiting toxicities are observed in these patients, then additional patients are randomized to arms III-VI. Patients in each arm receive vaccine on day 0 and at months 1, 2, 3, 6, 9, and 12. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: peptide 946 plus QS-21 | Experimental | Biological: QS21, Biological: p946100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant |
| Group 2. p946 plus IFA | Experimental | Biological: IFA (incomplete Freund's adjuvant), Biological: p946100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant |
| Group 3: p946 plus Tet-p plus QS-21 | Experimental | Biological: QS21, Biological: p946, Biological: Tet-p100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant |
| Group 4. p946, Tet-p plus IFA | Experimental | Biological: IFA (incomplete Freund's adjuvant), Biological: p946, Biological: Tet-p100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant |
| Group 5: p946/Tet-p plus QS-21 | Experimental | Biological: QS21, Biological: p946/tet-p282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant |
| Group 6. p946/Tet-p plus IFA | Experimental | Biological: IFA (incomplete Freund's adjuvant), Biological: p946/tet-p282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above)
- Age: 18 to 79
- Performance status: ECOG 0-2
- Life expectancy: Greater than 12 months
- Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL
Key exclusion criteria (15 listed)
- patients currently receiving cytotoxic chemotherapy or who have received that therapy within the preceding 3 months
- known or suspected allergies to any component of the treatment vaccine
- unresectable tumor llikely to cause symptoms and for which therapy is anticipated within 3 months.
- receiving acute treatment for seriouis infection within 14 days.
- Patients with bulky disease, or with multiple brain metastases, but solitary brain metastases treated successfully with surgery or gamma knife may be eligible.
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 |
|---|---|---|
| QS21vaccine adjuvant | Biological | Group 1: peptide 946 plus QS-21, Group 3: p946 plus Tet-p plus QS-21, Group 5: p946/Tet-p plus QS-21 |
| IFA (incomplete Freund's adjuvant)Also: Montanide ISA-51, from Seppic.Peptides emulsified in IFA. | Biological | Group 2. p946 plus IFA, Group 4. p946, Tet-p plus IFA, Group 6. p946/Tet-p plus IFA |
| p946Also: peptide 946, gp100 [280-288], YLEPGPVTAThis a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen. | Biological | Group 1: peptide 946 plus QS-21, Group 2. p946 plus IFA, Group 3: p946 plus Tet-p plus QS-21, Group 4. p946, Tet-p plus IFA |
| p946/tet-pAlso: peptide 946-tetanus peptide conjugate melanoma vaccineThis peptide is a longer version of p946 (gp100 [280-288]) sythesized colinearly with the tetanus helper peptide (Tet-p) | Biological | Group 5: p946/Tet-p plus QS-21, Group 6. p946/Tet-p plus IFA |
| Tet-pAlso: tetanus peptide melanoma vaccinemodified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells. | Biological | Group 3: p946 plus Tet-p plus QS-21, Group 4. p946, Tet-p plus IFA |
Primary outcome
Safety: Grade 3 Adverse Events
Time frame: Up to 24 months after last vaccine
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria
1 secondary outcome
Immunogenicity of Each Vaccine Regimen
Time frame: up to 12 months since enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 11595689Slingluff CL Jr, Yamshchikov G, Neese P, Galavotti H, Eastham S, Engelhard VH, Kittlesen D, Deacon D, Hibbitts S, Grosh WW, Petroni G, Cohen R, Wiernasz C, Patterson JW, Conway BP, Ross WG. Phase I trial of a melanoma vaccine with gp100(280-288) peptide and tetanus helper peptide in adjuvant: immunologic and clinical outcomes. Clin Cancer Res. 2001 Oct;7(10):3012-24.
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Craig L. Slingluff, MD study chair
University of Virginia
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 QS21, IFA (incomplete Freund's adjuvant) and p946 in people with Melanoma (Skin), run by University of Virginia 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 7 inclusion and 15 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 20 Nov 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?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety: Grade 3 Adverse Events (time frame: Up to 24 months after last vaccine). 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 NCT00003224, 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 20 Nov 2014.