Recurrent MelanomaPhase 1NCT01744171
Vaccine Therapy in Treating Patients With Advanced Stage III-IV Melanoma
A Phase 1 study testing Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine and Laboratory Biomarker Analysis in people with Recurrent Melanoma and Stage IIIB Skin Melanoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with stage III-IV melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
- What is being tested?
- Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine and Laboratory Biomarker Analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2013to 11 Jun 2018
- 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count (ANC) > 1500/uL
- Platelets >= 120,000/uL
- Total bilirubin =< 1.5 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN)
- Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min)
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- Blood urea nitrogen (BUN) =< 1.5 x ULN
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam
- An anticipated overall survival of at least 6 months
- Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
- Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)
- Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)
- Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)
Who cannot join
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
- Received an investigational agent within 30 days prior to enrollment
- Melanoma specific systemic therapy within 30 days of enrollment
- A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease
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- Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded
- Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis
- Previous history of splenectomy or whole spleen radiation
- Systemic immunoglobulin therapy within the last 30 days
- Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens
- Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years
- Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with stage III-IV melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients.
SECONDARY OBJECTIVES:
- To examine the effect of the recombinant human hsp110-gp100 chaperone complex vaccine on measurable clinical tumor.
II. To determine gp100 and hsp110 specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine.
III. To determine the effect of dose and serial administration of the chaperone complex vaccine on cell mediated and humoral immune responses.
IV. To quantify patient characteristics (human leukocyte antigen [HLA] subtype, immune cell function, etc.) that may correlate with immune response to the chaperone complex vaccine.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant hsp110-gp100 chaperone complex vaccine intradermally (ID) on days 1, 15, and 43 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up for 6 months.
- Conditions
- Recurrent Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma
- Being tested
- Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine, Laboratory Biomarker Analysis
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Hsp110-gp100 Chaperone Complex VaccineBiological
Given ID
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (recombinant hsp110-gp100 chaperone complex vaccine) | Experimental | Patients receive recombinant hsp110-gp100 chaperone complex vaccine ID on days 1, 15, and 43 in the absence of unacceptable toxicity. Receives: Biological: Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of recombinant human hsp110-gp100 chaperone complex melanoma vaccine based on the probability of dose-limiting toxicity (DLT), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4
DLT is defined as grade 3 or 4 toxicity or grade 3 injection site toxicity, with the exception of grade 3 rigors/chills which will be tolerated for 48-72 hours if attributable to vaccine reaction.
Measured: Up to 30 days after the last vaccine dose
Secondary outcomes (1)
Objective tumor response according to RECIST version 1.1
Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start26 Mar 2013
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Why it stopped: Study was Suspended since 2018; PI decided to terminate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MelanomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kane, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744171
- Sponsor's protocol ID
- I 215912
- Other IDs
- NCI-2012-02231, I 215912
- Status last verified
- Jul 2022
- First submitted
- 4 Dec 2012
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma
- ClinicalTrials.gov ID
- NCT01744171
- Acronym / sponsor ID
- I 215912
- Conditions
- Recurrent Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was Suspended since 2018; PI decided to terminate.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 26 Mar 2013 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 6 Dec 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 phase I trial studies the side effects and best dose of vaccine therapy in treating patients with stage III-IV melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients.
SECONDARY OBJECTIVES:
- To examine the effect of the recombinant human hsp110-gp100 chaperone complex vaccine on measurable clinical tumor.
II. To determine gp100 and hsp110 specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine.
III. To determine the effect of dose and serial administration of the chaperone complex vaccine on cell mediated and humoral immune responses.
IV. To quantify patient characteristics (human leukocyte antigen [HLA] subtype, immune cell function, etc.) that may correlate with immune response to the chaperone complex vaccine.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant hsp110-gp100 chaperone complex vaccine intradermally (ID) on days 1, 15, and 43 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (recombinant hsp110-gp100 chaperone complex vaccine) | Experimental | Biological: Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine, Other: Laboratory Biomarker AnalysisPatients receive recombinant hsp110-gp100 chaperone complex vaccine ID on days 1, 15, and 43 in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count (ANC) > 1500/uL
- Platelets >= 120,000/uL
- Total bilirubin =< 1.5 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN)
Key exclusion criteria (13 listed)
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
- Received an investigational agent within 30 days prior to enrollment
- Melanoma specific systemic therapy within 30 days of enrollment
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 |
|---|---|---|
| Recombinant Human Hsp110-gp100 Chaperone Complex VaccineGiven ID | Biological | Treatment (recombinant hsp110-gp100 chaperone complex vaccine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (recombinant hsp110-gp100 chaperone complex vaccine) |
Primary outcome
MTD of recombinant human hsp110-gp100 chaperone complex melanoma vaccine based on the probability of dose-limiting toxicity (DLT), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4
Time frame: Up to 30 days after the last vaccine dose
DLT is defined as grade 3 or 4 toxicity or grade 3 injection site toxicity, with the exception of grade 3 rigors/chills which will be tolerated for 48-72 hours if attributable to vaccine reaction.
1 secondary outcome
Objective tumor response according to RECIST version 1.1
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Study was Suspended since 2018; PI decided to terminate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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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 Kane principal investigator
Roswell Park Cancer Institute
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 Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine and Laboratory Biomarker Analysis in people with Recurrent Melanoma and Stage IIIB Skin Melanoma, run by Roswell Park Cancer Institute 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 15 inclusion and 13 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 22 Jul 2022. 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: Study was Suspended since 2018; PI decided to terminate.). 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?
MTD of recombinant human hsp110-gp100 chaperone complex melanoma vaccine based on the probability of dose-limiting toxicity (DLT), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (time frame: Up to 30 days after the last vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.