Melanoma (Skin)Phase 1/2NCT00118274
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
A Phase 1/2 study testing incomplete Freund's adjuvant, melanoma helper peptide vaccine and multi-epitope melanoma peptide vaccine in people with Melanoma (Skin), run by Craig L Slingluff, Jr at 3 sites in United States.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- incomplete Freund's adjuvant, melanoma helper peptide vaccine and multi-epitope melanoma peptide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2005to Feb 2010
- Phase
- Phase 1/2
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed melanoma
- Cutaneous, mucosal, or primary melanoma
- Stage IIB-IV disease
- Has undergone surgical resection or stereotactic radiosurgery for malignant melanoma ≥ 1 week but ≤ 6 months ago
- No clinical or radiological evidence of disease after surgical resection or stereotactic radiosurgery by chest x-ray or CT scan*, abdominal and pelvic CT scan*, and head CT scan or MRI NOTE: *Positron emission tomography scan/CT fusion scan may replace scans of the chest, abdomen, and pelvis
- Must have ≥ 2 intact (undissected) axillary and/or inguinal lymph node basins
- HLA-A1, -A2, or -A3 positive AND HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
- Ineligible for OR refused interferon
- No ocular melanoma
- Brain metastases allowed provided all of the following criteria are met:
- No more than 3 total brain metastases
- Each metastasis ≤ 2 cm in diameter at the time of study entry
- Each metastasis was completely removed by surgery or treated with stereotactic radiosurgery
- No evidence of brain metastasis progression since the most recent treatment
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 9 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Lactic dehydrogenase ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Hepatitis C negative
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No New York Heart Association class III or IV heart disease
Immunologic
- HIV negative
- No known or suspected allergy to any component of the study vaccines
- No autoimmune disorder with visceral involvement
- No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- The following immunologic conditions are allowed:
- Laboratory evidence of autoimmune disease (e.g., positive anti-nuclear antibody titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring non-steroidal anti-inflammatory drugs
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight ≥ 110 lbs
- No uncontrolled diabetes
- Hemoglobin A1C < 7%
- No medical contraindication or potential problem that would preclude study compliance
- No other malignancy except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast (ductal or lobular) or cervix, or other successfully treated cancer without distant metastasis with no evidence of recurrence or metastasis for > 5 years
- No known active addiction to alcohol or drugs
- No recent (within the past year) or ongoing illicit IV drug use
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior vaccination with any of the synthetic peptides used in this study
- Prior vaccinations (containing agents other than the synthetic peptides used in this study) that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago
- More than 4 weeks since prior and no concurrent interferon (e.g., Intron-A®), interleukins (e.g., Proleukin®), or growth factors (e.g., Procrit®, Aranesp®, or Neulasta®)
- More than 4 weeks since prior and no concurrent allergy desensitization injections
- No influenza vaccines for at least 2 weeks before or after study vaccine administration
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- No concurrent chemotherapy, including nitrosoureas
Endocrine therapy
- More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids
- No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, or Azmacort®)
- Prior or concurrent topical corticosteroids allowed
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since other prior and no concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- More than 4 weeks since prior and no other concurrent investigational agents
- More than 30 days since prior and no concurrent participation in another clinical study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants With Resected Melanoma
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma.
PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of adjuvant vaccine therapy comprising multi-epitope melanoma peptides (MP) and multi-epitope melanoma helper peptides (MHP) emulsified in Montanide ISA-51 in patients with resected stage IIB-IV melanoma.
- Determine the safety of administering cyclophosphamide before vaccination in these patients.
- Compare the magnitude of immune response against vaccination comprising MP in combination with either MHP or tetanus toxoid helper peptide (TET) emulsified in Montanide ISA-51 with vs without cyclophosphamide in these patients.
Secondary
- Compare the response rate and persistence of immune responses in patients treated with these regimens.
- Compare the magnitude of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients.
- Compare the response rate and persistence of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients.
- Determine the delayed-type hypersensitivity response to the peptide components of these vaccines in these patients.
- Compare, preliminarily, disease-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to HLA-type (HLA-A1 positive vs HLA-A2 positive, HLA-A1 negative, or -A3 negative vs HLA-A3 positive, or -A1 negative) and participating center (University of Virginia [UVA] vs non-UVA). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccine comprising multi-epitope melanoma peptides (MP) and tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally (ID) and subcutaneously (SC) on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
- Arm II: Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine as in arm I.
- Arm III: Patients receive vaccine comprising MP and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 ID and SC on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
- Arm IV: Patients receive cyclophosphamide as in arm II. Patients then receive vaccine as in arm III.
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 173 patients will be accrued for this study within 2 years.
- Conditions
- Melanoma (Skin)
- Being tested
- incomplete Freund's adjuvant, melanoma helper peptide vaccine, multi-epitope melanoma peptide vaccine, tetanus toxoid helper peptide, cyclophosphamide
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incomplete Freund's adjuvantBiological
Given intradermally and subcutaneously
melanoma helper peptide vaccineBiological
Given intradermally and subcutaneously
multi-epitope melanoma peptide vaccineBiological
Given intradermally and subcutaneously
tetanus toxoid helper peptideBiological
Given intradermally and subcutaneously
cyclophosphamideDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. Receives: Biological: incomplete Freund's adjuvant; Biological: multi-epitope melanoma peptide vaccine; Biological: tetanus toxoid helper peptide |
| Arm II | Experimental | Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. Receives: Biological: incomplete Freund's adjuvant; Biological: multi-epitope melanoma peptide vaccine; Biological: tetanus toxoid helper peptide; Drug: cyclophosphamide |
| Arm III | Experimental | Patients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. Receives: Biological: incomplete Freund's adjuvant; Biological: melanoma helper peptide vaccine; Biological: multi-epitope melanoma peptide vaccine |
| Arm IV | Experimental | Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. Receives: Biological: incomplete Freund's adjuvant; Biological: melanoma helper peptide vaccine; Biological: multi-epitope melanoma peptide vaccine; Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Peptide Vaccines
Number of participants with dose-limiting toxicities
Measured: 30 days after receiving the last dose of study drug, up to week 52
Secondary outcomes (1)
Immunogenicity (CD8+ T Cell Response to 12 Melanoma Peptides, 12MP) as Measured by Elispot Assay, up to Day 50
The primary end point was the maximum cumulative circulating CD8+ T cell response to 12 melanoma peptides (12MP) measured by ELISpot assay over the first six vaccines (to day 50).
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startMar 2005
- Primary completionFeb 2010
- Study completionFeb 2010
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 (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L. Slingluff, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118274
- Sponsor's protocol ID
- 11491
- Other IDs
- UVACC-34104, UVACC-MEL-44, UVACC-GCRC-CLS013, UVACC-HITC-02620, MDA-2005-0070
- Status last verified
- Mar 2021
- First submitted
- 8 Jul 2005
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Slingluff CL Jr, Petroni GR, Chianese-Bullock KA, Smolkin ME, Ross MI, Haas NB, von Mehren M, Grosh WW. Randomized multicenter trial of the effects of melanoma-associated helper peptides and cyclophosphamide on the immunogenicity of a multipeptide melanoma vaccine. J Clin Oncol. 2011 Jul 20;29(21):2924-32. doi: 10.1200/JCO.2010.33.8053. Epub 2011 Jun 20.
PubMed 21690475Ninmer EK, Zhu H, Chianese-Bullock KA, von Mehren M, Haas NB, Ross MI, Dengel LT, Slingluff CL Jr. Multipeptide vaccines for melanoma in the adjuvant setting: long-term survival outcomes and post-hoc analysis of a randomized phase II trial. Nat Commun. 2024 Mar 22;15(1):2570. doi: 10.1038/s41467-024-46877-6.
PubMed 38519525
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants With Resected Melanoma
- ClinicalTrials.gov ID
- NCT00118274
- Acronym / sponsor ID
- 11491
- Conditions
- Melanoma (Skin)
- Keywords
- stage II melanoma, stage III melanoma, stage IV melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005 (actual)
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 20 Apr 2021
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 peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma.
PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of adjuvant vaccine therapy comprising multi-epitope melanoma peptides (MP) and multi-epitope melanoma helper peptides (MHP) emulsified in Montanide ISA-51 in patients with resected stage IIB-IV melanoma.
- Determine the safety of administering cyclophosphamide before vaccination in these patients.
- Compare the magnitude of immune response against vaccination comprising MP in combination with either MHP or tetanus toxoid helper peptide (TET) emulsified in Montanide ISA-51 with vs without cyclophosphamide in these patients.
Secondary
- Compare the response rate and persistence of immune responses in patients treated with these regimens.
- Compare the magnitude of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients.
- Compare the response rate and persistence of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients.
- Determine the delayed-type hypersensitivity response to the peptide components of these vaccines in these patients.
- Compare, preliminarily, disease-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to HLA-type (HLA-A1 positive vs HLA-A2 positive, HLA-A1 negative, or -A3 negative vs HLA-A3 positive, or -A1 negative) and participating center (University of Virginia [UVA] vs non-UVA). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccine comprising multi-epitope melanoma peptides (MP) and tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally (ID) and subcutaneously (SC) on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
- Arm II: Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine as in arm I.
- Arm III: Patients receive vaccine comprising MP and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 ID and SC on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
- Arm IV: Patients receive cyclophosphamide as in arm II. Patients then receive vaccine as in arm III.
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 173 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: incomplete Freund's adjuvant, Biological: multi-epitope melanoma peptide vaccine, Biological: tetanus toxoid helper peptidePatients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. |
| Arm II | Experimental | Biological: incomplete Freund's adjuvant, Biological: multi-epitope melanoma peptide vaccine, Biological: tetanus toxoid helper peptide, Drug: cyclophosphamidePatients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. |
| Arm III | Experimental | Biological: incomplete Freund's adjuvant, Biological: melanoma helper peptide vaccine, Biological: multi-epitope melanoma peptide vaccinePatients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. |
| Arm IV | Experimental | Biological: incomplete Freund's adjuvant, Biological: melanoma helper peptide vaccine, Biological: multi-epitope melanoma peptide vaccine, Drug: cyclophosphamidePatients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365. |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| incomplete Freund's adjuvantGiven intradermally and subcutaneously | Biological | Arm I, Arm II, Arm III, Arm IV |
| melanoma helper peptide vaccineGiven intradermally and subcutaneously | Biological | Arm III, Arm IV |
| multi-epitope melanoma peptide vaccineGiven intradermally and subcutaneously | Biological | Arm I, Arm II, Arm III, Arm IV |
| tetanus toxoid helper peptideGiven intradermally and subcutaneously | Biological | Arm I, Arm II |
| cyclophosphamideGiven IV | Drug | Arm II, Arm IV |
Primary outcome
Safety of the Peptide Vaccines
Time frame: 30 days after receiving the last dose of study drug, up to week 52
Number of participants with dose-limiting toxicities
1 secondary outcome
Immunogenicity (CD8+ T Cell Response to 12 Melanoma Peptides, 12MP) as Measured by Elispot Assay, up to Day 50
Time frame: 50 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21690475Slingluff CL Jr, Petroni GR, Chianese-Bullock KA, Smolkin ME, Ross MI, Haas NB, von Mehren M, Grosh WW. Randomized multicenter trial of the effects of melanoma-associated helper peptides and cyclophosphamide on the immunogenicity of a multipeptide melanoma vaccine. J Clin Oncol. 2011 Jul 20;29(21):2924-32. doi: 10.1200/JCO.2010.33.8053. Epub 2011 Jun 20.
- Derived from this study: PubMed 38519525Ninmer EK, Zhu H, Chianese-Bullock KA, von Mehren M, Haas NB, Ross MI, Dengel LT, Slingluff CL Jr. Multipeptide vaccines for melanoma in the adjuvant setting: long-term survival outcomes and post-hoc analysis of a randomized phase II trial. Nat Commun. 2024 Mar 22;15(1):2570. doi: 10.1038/s41467-024-46877-6.
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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.
Craig L. Slingluff, MD principal investigator
University of Virginia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing incomplete Freund's adjuvant, melanoma helper peptide vaccine and multi-epitope melanoma peptide vaccine in people with Melanoma (Skin), run by Craig L Slingluff, Jr at 3 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 20 Apr 2021). 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 of the Peptide Vaccines (time frame: 30 days after receiving the last dose of study drug, up to week 52). 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 NCT00118274, which also lists 2 linked publications.
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 Apr 2021.