Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
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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 |
- - Rate of Relapse-free Survival at 18 months. [ Time Frame: 18 months ]
- 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 |
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| 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 | |
| St Georges Hospital | |
| London, United Kingdom, SW17 0RE | |
| Royal Marsden Hospital | |
| London, United Kingdom, SW3 6JJ | |
| Mount Vernon Hospital | |
| Northwood, United Kingdom, HA6 2RN | |
| Weston Park Hospital | |
| Sheffield, United Kingdom, S10 2SJ | |
| Southampton University Hospitals | |
| Southampton, United Kingdom, SO16 6YD | |
| 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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013