Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma

This study has been completed.
Sponsor:
Collaborator:
Cancer Research Institute
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00199901
First received: September 16, 2005
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Melanoma
Biological: NY-ESO-1 ISCOMATRIX®
Biological: ISCOMATRIX® adjuvant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage IIc, III or IV Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • - Rate of Relapse-free Survival at 18 months. [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 18 months ]
  • NY-ESO-1 immunity [ Time Frame: 18 months ]
  • Relapse-free Survival and Overall Survival [ Time Frame: 18 months + ]

Enrollment: 111
Study Start Date: September 2005
Study Completion Date: December 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaccine
NY-ESO-1 ISCOMATRIX® vaccine
Biological: NY-ESO-1 ISCOMATRIX®

100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.

Each patient will receive four intramuscular injections of either NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).

Placebo Comparator: Adjuvant Alone
ISCOMATRIX® adjuvant alone
Biological: ISCOMATRIX® adjuvant

120 μg of ISCOMATRIX® alone.

Each patient will receive four intramuscular injections of either NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 pt 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199901

Locations
Australia, New South Wales
Sydney Melanoma Unit - Royal Prince Alfred Hospital
Camperdown (Sydney), New South Wales, Australia, 2050
Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, 2298
Australia, Queensland
Mater Medical Centre, Princess Alexandra Hospital
Woolloongabba (Brisbane), Queensland, Australia, 4102
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Austin Health (Ludwig Institute Oncology Unit)
Heidelberg (Melbourne), Victoria, Australia, 3084
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands (Perth), Western Australia, Australia, 6009
New Zealand
University of Auckland (Waitemata DHB)
Auckland, New Zealand
United Kingdom
University Hospital - Birmingham
Birmingham, United Kingdom, B29 6JD
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 2QQ
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
St Georges Hospital
London, United Kingdom, SW17 0RE
Mount Vernon Hospital
Northwood, United Kingdom, HA6 2RN
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Southampton University Hospitals
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Cancer Research Institute
Investigators
Study Chair: Prof. Jonathan S Cebon, MBBS PhD Ludwig Institute for Cancer Research
Principal Investigator: Prof. Martin Gore, MBBS PhD The Royal Marsden Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199901     History of Changes
Other Study ID Numbers: LUD2003-009
Study First Received: September 16, 2005
Last Updated: February 27, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe - New Zealand Medicines and Medical Devices Safety Authority, NZ Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ludwig Institute for Cancer Research:
Phase II
Randomized Controlled Trial
Double-Blind
Cancer Vaccine
NY-ESO-1 protein, human
ISCOMATRIX, immunological adjuvant

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 20, 2014