MelanomaPhase 1Mel 51NCT00977145
Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma
A Phase 1 study testing A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1 in people with Melanoma, run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
The goals of this study are to evaluate 1) the safety of administration of intratumoral interferon gamma with a peptide-based vaccine, in patients with melanoma and 2) the biological effects of the vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2012
- 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
- Participants with stage IIIB, IIIC or IV melanoma. Staging must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on the revised AJCC staging system.
- Patients must have adequate cutaneous or subcutaneous metastases of melanoma readily accessible for biopsy to provide a minimum of 0.3 cm3 of tissue per biopsy (approximately 0.85 cm by 0.85 cm x 0.85 cm or five 2mm core biopsies) at each time point. Additionally, at least one of the subcutaneous or cutaneous metastases must be accessible to intratumoral IFN-gamma administration. Several scenarios may fulfill the tumor burden requirement. For example, a patient may have one large lesion from which core biopsies can be taken for the first and second biopsy time points and then the entire lesion excised for the final tissue sample. Alternatively, a patient may have three lesions, each ≥0.3 cm3, and these lesions would be excised sequentially as biopsies 1, 2 and 3. Other combinations are acceptable.
- The intent is to limit this study to patients with cutaneous or subcutaneous melanoma metastasis rather than lymph node metastasis. There may be cases where a subcutaneous nodule cannot be definitively characterized as a non-nodal metastasis at the start of the trial - these patients may be included.
- Participants with ocular, mucosal or unknown primaries and participants with multiple primaries will be eligible.
- Participants who have had brain metastases may be eligible in selected circumstances:
- Patients with less than or equal to 3 metastases may eligible as long as the following 3 criteria are true:
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- The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry.
- There has been no evident growth of any brain metastasis since treatment.
- No metastasis greater than 2 cm at the time of protocol entry
- Patients with greater than 3 metastases may be eligible if the above 3 criteria are met and if at least one year has elapsed since the last treatment.
- All participants must have:
- ECOG performance status of 0 or 1
- Ability and willingness to give informed consent
- Laboratory parameters - The following laboratory parameters will be required for all participants. If a lab value appears to be an error or a result of a transient or treatable condition, the investigator will use his/her clinical judgment to decide if the test may be repeated. The requirements for inclusion are as follows:
- HLA-A1, -A2, -A3, or -A11+
- ANC > 1000/mm3
- Platelets > 100,000/mm3
- Hgb > 9 g/dL
- HGBA1C < 7%
- Hepatic:
- AST and ALT ≤ 2.5 x upper limits of normal (ULN)
- Bilirubin ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Renal
- o Creatinine ≤ 1.5 x ULN
- Serology (within 6 months of study entry)
- HIV negative
- Hepatitis C negative
- LDH up to 2 x ULN
- Age 18 years or older at the time of trial entry
- Participants must have at least one intact (undissected) axillary and/or inguinal lymph node basin
Who cannot join
- Patients who have had brain metastases unless they meet the criteria outlined above in the inclusion criteria.
- Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Gamma knife or stereotactic radiosurgery may be administered within the prior 4 weeks, but must not be administered less than one week prior to study enrollment. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- Patients will not be eligible if there is clinically detectable melanoma deemed likely by the investigator to require intervention during the first 3 months of the study that would require premature discontinuation. Examples for such circumstances may include untreated bone metastases at risk for fracture, and rapidly progressive low volume disease.
- Patients with known or suspected allergies to any component of the vaccine.
- Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
- Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids)
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- Allergy desensitization injections.
- Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair®, Flovent®, Azmacort®) are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex®).
- Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
- Interferon therapy
- Interleukin-2 or other interleukins.
- Prior melanoma vaccinations may be an exclusion criterion in some circumstances:
- Patients who have recurred or progressed either after or during administration of a melanoma vaccine may be eligible to enroll 12 weeks following their last vaccination.
- Patients may have been vaccinated previously with peptide vaccines (including MELITAC 12.1 and similar vaccines) or with non-peptide vaccines.
- Other investigational drugs or investigational therapy if the patient is currently taking those drugs/therapy, or if they have received the drugs/therapy within 1 month.
- Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first vaccine dose. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Women must also not be breast feeding. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
- Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
- Patients classified according to the New York Heart Association classification as having Class III or IV heart disease.
- Patients with a body weight < 110 lbs because of the amount and frequency with which blood will be drawn
- Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:
- The presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring NSAID medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Evaluation of the Safety and Immunogenicity of Intratumoral Injection of Interferon Gamma During Vaccination in Patients With Subcutaneous or Cutaneous Metastases of Melanoma
The goals of this study are to evaluate 1) the safety of administration of intratumoral interferon gamma with a peptide-based vaccine, in patients with melanoma and 2) the biological effects of the vaccine. These include an examination of changes within the tumor following vaccination and the evaluation of T cell responses to the vaccine both in the blood and at the sight of tumor.
Read the detailed description
Melanoma vaccines have been associated with major regressions in a small percentage of patients with advanced measurable disease. This provides proof-of-principle of the potential for clinical benefit with melanoma vaccines however, the current response rate is low. Thus, there is a critical need for additional new therapies for melanoma, both for adjuvant therapy of high-risk resected melanoma and for therapy of patients who are not candidates for, or fail, other therapies in the setting of advanced disease.
It is generally agreed that one mechanism to improve the immunologic outcomes of vaccine therapy is to optimize T cell trafficking to the tumor site. CXCR3 is the chemokine receptor on T cells which directs them to sites of inflammation by following the chemokine gradient. The ligands for CXCR3 (CXCL9 (MIG), CXCL10 (IP-10) and CXCL11 (I-TAC)) are known to be induced by interferon gamma. This protocol proposes administering a peptide vaccine to activate tumor antigen-specific CD8+ T cells expressing CXCR3, followed by intratumoral interferon gamma to increase CXCR3 ligands (CXCL9-11) at the tumor site and recruit the CXCR3+ T cells.
The primary goals of the proposed work are to assess the safety of the combination of peptide vaccine and intratumoral interferon gamma and to assess the immunologic outcomes at the tumor site.
- Conditions
- Melanoma
- Being tested
- A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1
- Keywords
- melanoma, peptide vaccine, interferon gamma, immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1Biological
Vaccine regimen: The vaccines will be administered in two treatment cycles. During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, 15. During cycle two, three vaccines will be administered over a 9-week period on days 24, 43, 64. All participants will receive 12-MP (100 mcg each peptide) plus Peptide-tet (Peptide-tet; 200 mcg) administered in Montanide ISA-51 VG adjuvant. The vaccine will be administered subcutaneously (1 ml) and intradermally (1ml) at a single vaccination site.
Intratumoral Interferon regimen: On day 22, patients will have one or more tumor sites injected with 0.5-2 million IU of IFN-gamma each, with a maximum dose of 2 million IU of IFN-gamma administered per patient. The number of lesions that are injected will be dependent on the availability and size of the lesions.
| Study group | Role | What they receive |
|---|---|---|
| intratumoral IFN-gamma plus MELITAC 12.1, | Experimental | intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1, an emulsion of a mixture of 12 class I MHC-restricted melanoma-derived peptides (12-MP) and a class II MHC-restricted tetanus toxoid-derived helper peptide (Peptide-tet). Receives: Biological: A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To determine the safety of administration of intratumoral interferon gamma with a peptide-based vaccine in patients with cutaneous or subcutaneous metastases of melanoma.
Measured: 6 months
Biologic effect: To evaluate the biological effects of vaccine plus IFN-gamma at the tumor site, to include expression of CXCR3 ligands (CXCL9, CXCL10 & CXCL11) and the magnitude of infiltration of CD8+ CXCR3+ T cells and vaccine-specific T cells.
Measured: 6 months
Secondary outcomes (4)
To estimate the effects of vaccine on CXCR3 expression by circulating antigen-experienced CD4 and CD8 T cells.
Measured: 6 months
To estimate the effects of vaccine plus IFN-gamma on changes in the percentage of FoxP3+ CD25hi CD4+ (putative regulatory T cells, T regulatory cells) among tumor infiltrating T cells.
Measured: 6 months
To obtain preliminary data on the variability of immunologic parameters among multiple biopsies of subcutaneous or cutaneous metastases of melanoma.
Measured: 6 months
To obtain preliminary data on the clinical response of cutaneous or subcutaneous metastases of melanoma to the proposed combination regimen.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2012
Why it stopped: Closed short of the enrollment goal, due to slow enrollment and adequate data to address endpoints
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 MelanomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L. Slingluff, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977145
- Sponsor's protocol ID
- 14215
- Acronym
- Mel 51
- Status last verified
- Dec 2016
- First submitted
- 14 Sep 2009
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tran CA, Lynch KT, Meneveau MO, Katyal P, Olson WC, Slingluff CL Jr. Intratumoral IFN-gamma or topical TLR7 agonist promotes infiltration of melanoma metastases by T lymphocytes expanded in the blood after cancer vaccine. J Immunother Cancer. 2023 Feb;11(2):e005952. doi: 10.1136/jitc-2022-005952.
PubMed 36746511
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Immunogenicity of Intratumoral Injection of Interferon Gamma During Vaccination in Patients With Subcutaneous or Cutaneous Metastases of Melanoma
- ClinicalTrials.gov ID
- NCT00977145
- Acronym / sponsor ID
- Mel 51 / 14215
- Conditions
- Melanoma
- Keywords
- melanoma, peptide vaccine, interferon gamma, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed short of the enrollment goal, due to slow enrollment and adequate data to address endpoints
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2012 (actual)
- First posted
- 15 Sep 2009 (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.
The goals of this study are to evaluate 1) the safety of administration of intratumoral interferon gamma with a peptide-based vaccine, in patients with melanoma and 2) the biological effects of the vaccine. These include an examination of changes within the tumor following vaccination and the evaluation of T cell responses to the vaccine both in the blood and at the sight of tumor.
Detailed description
Melanoma vaccines have been associated with major regressions in a small percentage of patients with advanced measurable disease. This provides proof-of-principle of the potential for clinical benefit with melanoma vaccines however, the current response rate is low. Thus, there is a critical need for additional new therapies for melanoma, both for adjuvant therapy of high-risk resected melanoma and for therapy of patients who are not candidates for, or fail, other therapies in the setting of advanced disease.
It is generally agreed that one mechanism to improve the immunologic outcomes of vaccine therapy is to optimize T cell trafficking to the tumor site. CXCR3 is the chemokine receptor on T cells which directs them to sites of inflammation by following the chemokine gradient. The ligands for CXCR3 (CXCL9 (MIG), CXCL10 (IP-10) and CXCL11 (I-TAC)) are known to be induced by interferon gamma. This protocol proposes administering a peptide vaccine to activate tumor antigen-specific CD8+ T cells expressing CXCR3, followed by intratumoral interferon gamma to increase CXCR3 ligands (CXCL9-11) at the tumor site and recruit the CXCR3+ T cells.
The primary goals of the proposed work are to assess the safety of the combination of peptide vaccine and intratumoral interferon gamma and to assess the immunologic outcomes at the tumor site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intratumoral IFN-gamma plus MELITAC 12.1, | Experimental | Biological: A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1, an emulsion of a mixture of 12 class I MHC-restricted melanoma-derived peptides (12-MP) and a class II MHC-restricted tetanus toxoid-derived helper peptide (Peptide-tet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Participants with stage IIIB, IIIC or IV melanoma. Staging must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on the revised AJCC staging system.
- Patients must have adequate cutaneous or subcutaneous metastases of melanoma readily accessible for biopsy to provide a minimum of 0.3 cm3 of tissue per biopsy (approximately 0.85 cm by 0.85 cm x 0.85 cm or five 2mm core biopsies) at each time point. Additionally, at least one of the subcutaneous or cutaneous metastases must be accessible to intratumoral IFN-gamma administration. Several scenarios may fulfill the tumor burden requirement. For example, a patient may have one large lesion from which core biopsies can be taken for the first and second biopsy time points and then the entire lesion excised for the final tissue sample. Alternatively, a patient may have three lesions, each ≥0.3 cm3, and these lesions would be excised sequentially as biopsies 1, 2 and 3. Other combinations are acceptable.
- The intent is to limit this study to patients with cutaneous or subcutaneous melanoma metastasis rather than lymph node metastasis. There may be cases where a subcutaneous nodule cannot be definitively characterized as a non-nodal metastasis at the start of the trial - these patients may be included.
- Participants with ocular, mucosal or unknown primaries and participants with multiple primaries will be eligible.
- Participants who have had brain metastases may be eligible in selected circumstances:
Key exclusion criteria (24 listed)
- Patients who have had brain metastases unless they meet the criteria outlined above in the inclusion criteria.
- Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Gamma knife or stereotactic radiosurgery may be administered within the prior 4 weeks, but must not be administered less than one week prior to study enrollment. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- Patients will not be eligible if there is clinically detectable melanoma deemed likely by the investigator to require intervention during the first 3 months of the study that would require premature discontinuation. Examples for such circumstances may include untreated bone metastases at risk for fracture, and rapidly progressive low volume disease.
- Patients with known or suspected allergies to any component of the vaccine.
- Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
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 |
|---|---|---|
| A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1Vaccine regimen: The vaccines will be administered in two treatment cycles. During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, 15. During cycle two, three vaccines will be administered over a 9-week period on days 24, 43, 64. All participants will receive 12-MP (100 mcg each peptide) plus Peptide-tet (Peptide-tet; 200 mcg) administered in Montanide ISA-51 VG adjuvant. The vaccine will be administered subcutaneously (1 ml) and intradermally (1ml) at a single vaccination site. Intratumoral Interferon regimen: On day 22, patients will have one or more tumor sites injected with 0.5-2 million IU of IFN-gamma each, with a maximum dose of 2 million IU of IFN-gamma administered per patient. The number of lesions that are injected will be dependent on the availability and size of the lesions. | Biological | intratumoral IFN-gamma plus MELITAC 12.1, |
Primary outcome
Safety: To determine the safety of administration of intratumoral interferon gamma with a peptide-based vaccine in patients with cutaneous or subcutaneous metastases of melanoma.
Time frame: 6 months
Biologic effect: To evaluate the biological effects of vaccine plus IFN-gamma at the tumor site, to include expression of CXCR3 ligands (CXCL9, CXCL10 & CXCL11) and the magnitude of infiltration of CD8+ CXCR3+ T cells and vaccine-specific T cells.
Time frame: 6 months
4 secondary outcomes
To estimate the effects of vaccine on CXCR3 expression by circulating antigen-experienced CD4 and CD8 T cells.
Time frame: 6 months
To estimate the effects of vaccine plus IFN-gamma on changes in the percentage of FoxP3+ CD25hi CD4+ (putative regulatory T cells, T regulatory cells) among tumor infiltrating T cells.
Time frame: 6 months
To obtain preliminary data on the variability of immunologic parameters among multiple biopsies of subcutaneous or cutaneous metastases of melanoma.
Time frame: 6 months
To obtain preliminary data on the clinical response of cutaneous or subcutaneous metastases of melanoma to the proposed combination regimen.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Closed short of the enrollment goal, due to slow enrollment and adequate data to address endpoints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Derived from this study: PubMed 36746511Tran CA, Lynch KT, Meneveau MO, Katyal P, Olson WC, Slingluff CL Jr. Intratumoral IFN-gamma or topical TLR7 agonist promotes infiltration of melanoma metastases by T lymphocytes expanded in the blood after cancer vaccine. J Immunother Cancer. 2023 Feb;11(2):e005952. doi: 10.1136/jitc-2022-005952.
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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, M.D. principal investigator
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 A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1 in people with Melanoma, run by Craig L Slingluff, Jr 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 31 inclusion and 24 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: stopped early, as of the sponsor's last update on 16 Dec 2016. 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 was stopped early (reason given: Closed short of the enrollment goal, due to slow enrollment and adequate data to address endpoints). 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.
What does the primary outcome measure?
Safety: To determine the safety of administration of intratumoral interferon gamma with a peptide-based vaccine in patients with cutaneous or subcutaneous metastases of melanoma. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00977145, 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 16 Dec 2016.