MelanomaPhase 1NCT01622933
Multiple Antigen-Engineered DC Vaccine for Melanoma
A Phase 1 study testing DC Vaccine + IFN and AdVTMM2/DC Vaccination in people with Melanoma, run by Lisa H. Butterfield, Ph.D. at 1 site in United States.
Trial summary
This clinical trial is to determine if the addition of a standard of care drug, interferon-alfa 2b (IFN), with an investigation vaccine will have any affect on the immune system and/or your cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- DC Vaccine + IFN and AdVTMM2/DC Vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2017
- 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
- Ability and willing to give consent
- Patients age 18 and older with recurrent, inoperable stage III, IV, M1a, b or c melanoma (any tumor thickness and any number of lymph node involvement, and in-transit metastases, or distant metastases) (AJCC).
- Previously treated with any form of therapy (including chemotherapy, radiation therapy, immunotherapy or surgery) for either metastatic, relapsed, or primary melanoma are eligible for this trial, provided the previous treatment was completed > 30 days prior to enrollment.
- Patients should have at least 2 subcutaneous, intracutaneous, and accessible tumor deposits, lymph node or other site available for biopsy purposes.
- Both men and women may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment and lactating females will have to discontinue breast feeding to be eligible.
- ECOG Performance Status of 0 or 1.
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- No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
- No previous evidence of opportunistic infection.
- Adequate baseline hematological and organ function as assessed by the following laboratory values within 28 days prior to study entry:
- Hemoglobin >/=9 g/dL Granulocytes >/=2,000/mm3 Lymphocytes >/=1000/mm3 Platelets >100,000/mm3 Serum Creatinine </=1.5 X the ULN AST, ALT, GGT, CPK, LDH, Alk phos </=2.5 X the ULN Serum Bilirubin </=1.5 X ULN In addition to study entry, the above hematological and organ function lab values along with the ECOG PS must be met prior to starting IFNα treatment.
- Subjects must have normal coagulation parameters as measured by PT/PTT,unless the subject is on an anticoagulation therapy.
Who cannot join
- Females of child-bearing potential (pre-menopausal) must have a negative serum beta-HCG pregnancy test at screening.
- Subjects with acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed more than 14 days prior to study treatment.
- Hep B \& C and HIV-infected patients, due to concerns in the ability to stimulate an effective immune response (determined by historical medical data).
- Subjects with acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
- Subjects with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents).
- Subjects with organ allografts.
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- Subjects must be free of known brain metastases by contrast-enhanced CT/MRI scans or have successfully-treated brain metastases and be asymptomatic for more than 1 month.
- Patients requiring immunosuppressive therapy for comorbid conditions.
- Concomitant Medication and Treatment: All allowed medications or treatments should be kept to a minimum and recorded. All questions regarding concomitant medications should be referred to the Investigator.
- Long term concurrent medications and/or treatments Not Allowed: Corticosteroids, chemotherapy, cyclosporin A. Short term (approximately 1 week) use of topical, low-dose or inhaled steroids may be allowed at the discretion of the investigator. Injectables not allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase I Trial Testing Multiple Antigen-Engineered DC Followed by IFNa2b Boost for Immunization of HLA-Unrestricted Melanoma Patients
This clinical trial is to determine if the addition of a standard of care drug, interferon-alfa 2b (IFN), with an investigation vaccine will have any affect on the immune system and/or your cancer. The investigational vaccine will be made with genes that are specific to melanoma and will be given intradermally (i.d.) every two weeks for a total of 3 vaccines.
After the vaccines, subjects will be randomized to either receive a boost of high dose IFN or no boost. IFN will be administered intravenously (into a vein) for 5 consecutive days (Monday through Friday) every week for 4 weeks. Administration will begin approximately 30 days (± 7 days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of randomization. All subsequent procedure dates for Group A will be based on the date of the first dose of IFNα2b.
Read the detailed description
This is a Phase I, single site study to evaluate the immunological effects of autologous DC transduced with the MART-1, tyrosinase and MAGE-A6 (melanoma associated antigens, MAA) genes in 30 subjects with recurrent, unresectable stage III, IV metastatic melanoma (M1a, M1b, M1c). AdVTMM2-transduced DC, 10e7, will be given intradermally (i.d.) every two weeks for a total of 3 vaccines.
After the DC vaccines, subjects will be randomized to either receive a boost of high dose IFNa2b or no boost.
Subjects randomized to receive the IFNa2b boost will receive Interferon-a2b, 20 MU/m2/d (rounded to the nearest 1 million units) administered intravenously for 5 consecutive days (Monday through Friday) every week for 4 weeks (induction). Administration will begin approximately 30 days (± 7 days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of randomization. All subsequent procedure dates for Group A will be based on the date of the first dose of IFNα2b..
The end-points of this study are local and systemic toxicity, immunological response, generation of determinant spreading and anti-tumor immunity, and clinical response.
- Conditions
- Melanoma
- Being tested
- DC Vaccine + IFN, AdVTMM2/DC Vaccination
- Keywords
- melanoma, recurrent, metastatic
- Medical subject headings
- Melanoma, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC Vaccine + IFNBiological
Also called Interferon Alfa - 2b, Intron A, IFN-alpha 2b, NSC #377523
Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection, or lower dose per sponsor's discretion.
IFN: 20 MU/m²/d (rounded to the nearest 1.0 million unit) administered IV x 5 consecutive days out of 7 (M-F) every week x 4 weeks.
AdVTMM2/DC VaccinationBiological
Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection.If cell counts are below the target, as few as 5x10e6 AdVTMM2/DC may be administered. However, at the discretion of the sponsor and/or the treating physician, a lower dose of DC that fulfills all of the other criteria for release may be administered on a case by case basis. If this occurs a dose exception form will be completed by the IMCPL, signed by the treating physician and filed in the subjects research records.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine + IFN | Experimental | Subjects will receive the investigational vaccine, intradermally, every other week for a total of 3 vaccines. Approximately 30 days after the last vaccine subjects will receive IFN intravenously 5 days a week for 4 weeks.
Leukapheresis will be required to be performed for each subject to be able to produce the investigational vaccine and for research testing. Leukapheresis and biopsies will be performed before the first vaccine, after the 3rd vaccine, and after the IFN treatment. Receives: Biological: DC Vaccine + IFN |
| Vaccine only | Experimental | Subjects will receive the investigational vaccine, intradermally, every other week for a total of 3 vaccines.
Leukapheresis will be required to be performed for each subject to be able to produce the investigational vaccine and for research testing. Leukapheresis and biopsies will be performed before the first vaccine, after the 3rd vaccine, and again approximately 2 months after the last vaccine. Receives: Biological: AdVTMM2/DC Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Types of adverse events associated with this Multiple Antigen-Engineered DC vaccine at the injection site and systemically.
Measured: 2 years
Secondary outcomes (1)
Immunological response (antigen-specific T cell activation)
Antigen-specific T cell activation will be monitored.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2016
- Study completionAug 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa H. Butterfield, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Lisa H. Butterfield, Ph.D., University of Pittsburgh
- Investigators
- John M Kirkwood, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622933
- Sponsor's protocol ID
- 09-021
- Other IDs
- 1P50CA121973-01A1
- Status last verified
- May 2016
- First submitted
- 14 Jun 2012
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Butterfield LH, Vujanovic L, Santos PM, Maurer DM, Gambotto A, Lohr J, Li C, Waldman J, Chandran U, Lin Y, Lin H, Tawbi HA, Tarhini AA, Kirkwood JM. Multiple antigen-engineered DC vaccines with or without IFNalpha to promote antitumor immunity in melanoma. J Immunother Cancer. 2019 Apr 24;7(1):113. doi: 10.1186/s40425-019-0552-x.
PubMed 31014399
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Testing Multiple Antigen-Engineered DC Followed by IFNa2b Boost for Immunization of HLA-Unrestricted Melanoma Patients
- ClinicalTrials.gov ID
- NCT01622933
- Acronym / sponsor ID
- 09-021
- Conditions
- Melanoma
- Keywords
- melanoma, recurrent, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lisa H. Butterfield, Ph.D.University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is to determine if the addition of a standard of care drug, interferon-alfa 2b (IFN), with an investigation vaccine will have any affect on the immune system and/or your cancer. The investigational vaccine will be made with genes that are specific to melanoma and will be given intradermally (i.d.) every two weeks for a total of 3 vaccines.
After the vaccines, subjects will be randomized to either receive a boost of high dose IFN or no boost. IFN will be administered intravenously (into a vein) for 5 consecutive days (Monday through Friday) every week for 4 weeks. Administration will begin approximately 30 days (± 7 days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of randomization. All subsequent procedure dates for Group A will be based on the date of the first dose of IFNα2b.
Detailed description
This is a Phase I, single site study to evaluate the immunological effects of autologous DC transduced with the MART-1, tyrosinase and MAGE-A6 (melanoma associated antigens, MAA) genes in 30 subjects with recurrent, unresectable stage III, IV metastatic melanoma (M1a, M1b, M1c). AdVTMM2-transduced DC, 10e7, will be given intradermally (i.d.) every two weeks for a total of 3 vaccines.
After the DC vaccines, subjects will be randomized to either receive a boost of high dose IFNa2b or no boost.
Subjects randomized to receive the IFNa2b boost will receive Interferon-a2b, 20 MU/m2/d (rounded to the nearest 1 million units) administered intravenously for 5 consecutive days (Monday through Friday) every week for 4 weeks (induction). Administration will begin approximately 30 days (± 7 days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of randomization. All subsequent procedure dates for Group A will be based on the date of the first dose of IFNα2b..
The end-points of this study are local and systemic toxicity, immunological response, generation of determinant spreading and anti-tumor immunity, and clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine + IFN | Experimental | Biological: DC Vaccine + IFNSubjects will receive the investigational vaccine, intradermally, every other week for a total of 3 vaccines. Approximately 30 days after the last vaccine subjects will receive IFN intravenously 5 days a week for 4 weeks. Leukapheresis will be required to be performed for each subject to be able to produce the investigational vaccine and for research testing. Leukapheresis and biopsies will be performed before the first vaccine, after the 3rd vaccine, and after the IFN treatment. |
| Vaccine only | Experimental | Biological: AdVTMM2/DC VaccinationSubjects will receive the investigational vaccine, intradermally, every other week for a total of 3 vaccines. Leukapheresis will be required to be performed for each subject to be able to produce the investigational vaccine and for research testing. Leukapheresis and biopsies will be performed before the first vaccine, after the 3rd vaccine, and again approximately 2 months after the last vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability and willing to give consent
- Patients age 18 and older with recurrent, inoperable stage III, IV, M1a, b or c melanoma (any tumor thickness and any number of lymph node involvement, and in-transit metastases, or distant metastases) (AJCC).
- Previously treated with any form of therapy (including chemotherapy, radiation therapy, immunotherapy or surgery) for either metastatic, relapsed, or primary melanoma are eligible for this trial, provided the previous treatment was completed > 30 days prior to enrollment.
- Patients should have at least 2 subcutaneous, intracutaneous, and accessible tumor deposits, lymph node or other site available for biopsy purposes.
- Both men and women may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment and lactating females will have to discontinue breast feeding to be eligible.
Key exclusion criteria (10 listed)
- Females of child-bearing potential (pre-menopausal) must have a negative serum beta-HCG pregnancy test at screening.
- Subjects with acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed more than 14 days prior to study treatment.
- Hep B \& C and HIV-infected patients, due to concerns in the ability to stimulate an effective immune response (determined by historical medical data).
- Subjects with acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
- Subjects with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents).
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 |
|---|---|---|
| DC Vaccine + IFNAlso: Interferon Alfa - 2b, Intron A, IFN-alpha 2b, NSC #377523Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection, or lower dose per sponsor's discretion. IFN: 20 MU/m²/d (rounded to the nearest 1.0 million unit) administered IV x 5 consecutive days out of 7 (M-F) every week x 4 weeks. | Biological | Vaccine + IFN |
| AdVTMM2/DC VaccinationVaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection.If cell counts are below the target, as few as 5x10e6 AdVTMM2/DC may be administered. However, at the discretion of the sponsor and/or the treating physician, a lower dose of DC that fulfills all of the other criteria for release may be administered on a case by case basis. If this occurs a dose exception form will be completed by the IMCPL, signed by the treating physician and filed in the subjects research records. | Biological | Vaccine only |
Primary outcome
Safety
Time frame: 2 years
Types of adverse events associated with this Multiple Antigen-Engineered DC vaccine at the injection site and systemically.
1 secondary outcome
Immunological response (antigen-specific T cell activation)
Time frame: 2 years
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 31 Aug 2017.
- Derived from this study: PubMed 31014399Butterfield LH, Vujanovic L, Santos PM, Maurer DM, Gambotto A, Lohr J, Li C, Waldman J, Chandran U, Lin Y, Lin H, Tawbi HA, Tarhini AA, Kirkwood JM. Multiple antigen-engineered DC vaccines with or without IFNalpha to promote antitumor immunity in melanoma. J Immunother Cancer. 2019 Apr 24;7(1):113. doi: 10.1186/s40425-019-0552-x.
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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.
John M Kirkwood, MD principal investigator
University of Pittsburgh
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 DC Vaccine + IFN and AdVTMM2/DC Vaccination in people with Melanoma, run by Lisa H. Butterfield, Ph.D. 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 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 2 years). 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 NCT01622933, 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 31 Aug 2017.