Clinical trial NCT00199901: Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
Official title: Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage Ilc, Illb, lIIc, or IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Phase II
Randomized Controlled Trial
Double-Blind
Cancer Vaccine
NY-ESO-1 protein, human
ISCOMATRIX®, immunological adjuvant
Lead sponsor: Ludwig Institute for Cancer Research
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2005-09-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.

Detailed description: NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for participants with Malignant Melanoma which has been removed, but is at high risk of recurrence.

Eligible participants are randomly allocated to a treatment arm. Treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months).

Participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. Off study, their own doctor will follow them for melanoma recurrence and survival.

Eligibility criteria: Inclusion Criteria:

* Histologically proven malignant melanoma.
* Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
* Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.
* Within six months of surgery for melanoma.
* Full recovery from surgery.
* No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (Previous adjuvant therapy accepted providing patient relapsed and resected after this.)
* Age 18 years or older.
* Able to give written informed consent.
* Vital laboratory parameters within normal range, or protocol specified ranges.

Exclusion Criteria:

* Other serious or significant illnesses.
* Resected cerebral metastases.
* Ocular melanoma.
* Other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ.
* Using immunosuppressive drugs.
* Anticoagulation.
* Known HIV positivity.
* Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).
* Not available for immunological and clinical follow-up assessments.
* Participation in prior clinical trial involving an investigational agent within last 4 weeks.
* Previous isolated limb perfusion (ILP).
* Pregnancy or breastfeeding.
* Refusal or inability to use effective means of contraception for women of childbearing potential.
* Mental impairment that may compromise ability to give informed consent and to comply with study requirements.

Primary outcomes:
measure: Rate of Relapse-free Survival at 18 Months
timeFrame: 18 months
Secondary outcomes:
measure: Number of Patients With Treatment -Emergent Adverse Events (TEAEs)
timeFrame: 18 months
measure: Relapse-Free Survival During the Entire Period of Observation (up to 6 Years).
timeFrame: through study completion; up to 6 years
measure: Overall Survival
timeFrame: through study completion; up to 6 years
measure: NY-ESO-1 Antibody Response at Baseline Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
timeFrame: Baseline
measure: NY-ESO-1 Antibody Response on Day 71 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
timeFrame: Day 71
measure: NY-ESO-1 Antibody Response on Day 197 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
timeFrame: Day 197
measure: NY-ESO-1 Antibody Response on Day 365 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
timeFrame: Day 365
measure: NY-ESO-1 Antibody Response at End of Study Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
timeFrame: End of Study (month 18)
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Sydney Melanoma Unit - Royal Prince Alfred Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Mater Medical Centre, Princess Alexandra Hospital
state: Queensland
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health (Ludwig Institute Oncology Unit)
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: University of Auckland (Waitemata DHB)
city: Birmingham
country: United Kingdom
facility: University Hospital - Birmingham
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: London
country: United Kingdom
facility: St Georges Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals
Study officials:
affiliation: Ludwig Institute for Cancer Research
name: Prof. Jonathan S Cebon, MBBS PhD
role: STUDY_CHAIR
affiliation: The Royal Marsden Hospital
name: Prof. Martin Gore, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: