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TumorsPhase 1NCT00821652

Randomized, Double Blind, Placebo-controlled Topical Resiquimod Adjuvant for NY-ESO-1 Protein Vaccination

A Phase 1 study testing NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod in people with Tumors, run by Nina Bhardwaj at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is designed to see if a course of injections containing the NY-ESO-1 protein (a tumor antigen, marker expressed by tumors); in combination with an immune stimulant (adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and safe in patients with surgically resected Stage IIB… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors
What is being tested?
NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
Feb 2009to Dec 2014
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

  • Patients will be eligible for enrollment if they fulfill the following criteria:
  • Histological diagnosis of surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC criteria) melanoma independent of NY-ESO-1 expression in a tumor biopsy
  • At least 4 weeks since surgery prior to first dosing of study agent.
  • Laboratory values within the following limits:
  • Hemoglobin > 10.0 g/dL Neutrophil count > 1.5 x l09/L Lymphocyte count > Lower limit of institutional normal Platelet count > 80 x l09/L Serum creatinine < 2.0 mg/dL Serum bilirubin < 2 x upper limit of institutional normal AST/ALT < 2 x upper limit of institutional normal
  • Patients must have an ECOG performance status of <2 (ECOG criteria published in [46])
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  • Life expectancy > 6 months.
  • Age > 18 years.
  • Able and willing to give written informed consent for participation in the trial (see Section 12.2)
  • Patients enrolled in the adjuvant setting must have received standard curative therapy, e.g., surgery, radiation. Alternatively, patients can enter after refusing standard curative therapy only if therapy was clearly discussed with the treating physician or if they have failed another biologic therapy due to toxicity.

Who cannot join

  • Patients will be excluded from the study if they fulfill any of the following criteria:
  • Serious illnesses, e.g., serious infections requiring antibiotics.
  • Previous bone marrow or stem cell transplant.
  • History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo.
  • Metastatic disease to the central nervous system.
  • Other malignancy prior to entry into the study.
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  • No radiation therapy, prior biological therapy or surgery within 4 weeks prior to first dose of study agent.
  • No prior chemotherapy or prior vaccine or immunotherapy.
  • Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination sites) or inhalational steroids are permitted. (See also Section 6.7 for restrictions/recommendations on 'Ancillary Therapy'.)
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
  • Pregnancy or lactation.
  • Women of childbearing potential not using a medically acceptable means of contraception.
  • Patients with known history of inflammatory skin disorders (e.g.,psoriasis, lupus) that may be exacerbated by Resiquimod.
  • Psychiatric or addictive disorders that may compromise the ability to give informed consent.
  • Lack of availability of the patient for immunological and clinical follow-up assessment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Phase I Randomized, Double-blind, Placebo-controlled Study of Topical Resiquimod as an Adjuvant for NY-ESO1 Protein+Montanide Vaccination in Patients With Tumors That Often Express NY-ESO-1

The study is designed to see if a course of injections containing the NY-ESO-1 protein (a tumor antigen, marker expressed by tumors); in combination with an immune stimulant (adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and safe in patients with surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC criteria) melanoma, a tumor that expresses NY-ESO-1. In addition, this study is designed to see if the patient's body's defense (immune) system can be boosted (strengthened) by this vaccine and if the addition of resiquimod to the vaccine makes this more likely.

Read the detailed description

There is no published data on the application of topical resiquimod in combination with an antigen in Montanide, therefore, this study includes a 2-part design where Part I represents a dose-escalation part with topical resiquimod in an open-label fashion. Part II represents the randomized part.

In Part I, 2 cohorts are planned: If no dose-limiting toxicity (DLT) occurs by day 8 of the last vaccination cycle in the last patient enrolled the first cohort, 3 additional patients (cohort 2) will be enrolled. If no DLT occurs by day 8 of the last vaccination cycle in the last patient enrolled the second cohort in Part I, the trial will proceed to Part II where patients will be randomized.

Conditions
Tumors
Being tested
NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod, NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo
Keywords
Tumor, NY-ESO-1 expression, Tumors that often express NY-ESO-1.
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NY-ESO-1 protein; Montanide ISA®-51 VG; ResiquimodDrug

    Part I: a cohort of 3 patients to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical resiquimod 1000 mg of the 0.2% gel on days 1, and 3. If no DLT observed, we will proceed to cohort 2 with Resiquimod dosing on days 1,3 and 5. If DLT is found in the second cohort, the trial will proceed to Part II; with the limited dosing for days 1 and 3 only, as used in the first cohort. If no DLT is found in second cohort, the trial will proceed to Part II with Resiquimod dosing for days1, 3 and 5.

  • NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placeboDrug

    Part II: Eligible patients will be randomized to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical placebo gel (Arm A) or topical resiquimod gel (Arm B) on days 1, 3 and 5; or resiquimod dosing regimen established in Part I. The cycles will be repeated every 3 weeks for a total of 4 cycles (on Study week 1, 4, 7 and 10). All procedures may occur within + 3 days of the planned date.

Study groups in NCT00821652
Study groupRoleWhat they receive
Dose-esclationOtherPart I represents a dose-escalation part with topical resiquimod in an open-label fashion.
Receives: Drug: NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod
2ExperimentalPart II: Eligible patients will be randomized to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical placebo gel (Arm A) or topical resiquimod gel (Arm B) on days 1, 3 and 5; or resiquimod dosing regimen established in Part I.
Receives: Drug: NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objectives of the study are to define the safety and immunogenicity of vaccination with NY-ESO-1 protein emulsified in Montanide® ISA-51 VG when given with or without the topical TLR 7/8 agonist resiquimod.

    Measured: Blood samples are obtained at baseline, 1 week after each vaccination, and at follow-up 1visit.

Secondary outcomes (1)

  1. To document tumor response by RECIST criteria if applicable. Skin section analysis of resiquimod/placebo treated site for immune cell infiltration and gene expression analysis. Investigation of polymorphisms for TLR7/8 through germline SNP analysis

    Measured: Skin biopsies will be obtained after the last vaccination cycle. Clinical hematology and biochemistry measurements will be taken at baseline, one week after the second vaccination and two to four weeks after the fourth vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2010
  4. Study completionDec 2014

Resources

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
Factorial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00821652
Sponsor's protocol ID
GCO 13-1390
Status last verified
Dec 2014
First submitted
12 Jan 2009
Last updated
8 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod in people with Tumors, run by Nina Bhardwaj 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 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2015. 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?

The primary objectives of the study are to define the safety and immunogenicity of vaccination with NY-ESO-1 protein emulsified in Montanide® ISA-51 VG when given with or without the topical TLR 7/8 agonist resiquimod. (time frame: Blood samples are obtained at baseline, 1 week after each vaccination, and at follow-up 1visit.). 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 NCT00821652.

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 8 Jan 2015.

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