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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00518206




Registration number
NCT00518206
Ethics application status
Date submitted
16/08/2007
Date registered
20/08/2007

Titles & IDs
Public title
Study of NY-ESO-1 ISCOMATRIX® in Patients With Measurable Stage III or IV Melanoma
Scientific title
A Phase II Study of the Clinical and Immunological Effects of NY-ESO-1 ISCOM® Vaccine in Patients With Measurable Stage III and IV Malignant Melanoma
Secondary ID [1] 0 0
CTN Trial No.: 2007/123
Secondary ID [2] 0 0
LUD2002-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NY-ESO-1 ISCOMATRIX® vaccine
Treatment: Drugs - Cyclophosphamide

Experimental: Cohort 1 - NY-ESO-1 ISCOM vaccine (100 µg of the NY-ESO-1 protein formulated with 120 µg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.

Experimental: Cohort 2 - Cyclophosphamide (300 mg/m\^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 µg of the NY-ESO-1 protein formulated with 120 µg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.


Treatment: Other: NY-ESO-1 ISCOMATRIX® vaccine
NY-ESO-1 ISCOM vaccine (100 µg of the NY-ESO-1 protein formulated with 120 µg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide (300 mg/m\^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 µg of the NY-ESO-1 protein formulated with 120 µg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Best Overall Tumor Response
Timepoint [1] 0 0
Up to 22 months
Secondary outcome [1] 0 0
Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine
Timepoint [1] 0 0
Up to 22 months
Secondary outcome [2] 0 0
Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions
Timepoint [2] 0 0
Up to 22 months
Secondary outcome [3] 0 0
Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine
Timepoint [3] 0 0
Up to 22 months
Secondary outcome [4] 0 0
Number of Subjects With Treatment-emergent Adverse Events
Timepoint [4] 0 0
Up to 22 months

Eligibility
Key inclusion criteria
1. Stage IV (metastatic) or unresectable stage III malignant melanoma.
2. Measurable disease using RECIST.
3. No other effective therapy available or appropriate.
4. Expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) or reverse transcription-polymerase chain reaction (RT-PCR).
5. Expected survival of at least 4 months.
6. Karnofsky performance status of = 70%.
7. Within 3 weeks prior to first administration of study drug, the following laboratory parameters were required to be within the ranges specified:

* Hemoglobin = 100 g/L
* Platelets = 100 x 10^9/L
* International normalized ratio = 2.0
* Creatinine = 0.2 mmol/L
* Bilirubin = 30 mmol/L
8. Age = 18 years.
9. Able and willing to give written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would have interfered with the ability of the patient to complete all study requirements.
2. Other malignancy within last 3 years, except for treated melanoma or non-melanoma skin cancer or cervical cancer in situ.
3. Known immunodeficiency.
4. Known human immunodeficiency virus positivity.
5. Concomitant systemic treatment with corticosteroids, anti-histaminic drugs, or nonsteroidal anti-inflammatory drugs. Specific cyclooxygenase-2 (COX-2) inhibitors, low-dose aspirin for the prevention of an acute cardiovascular event, and topical or inhaled steroids were permitted.
6. Chemotherapy and/or radiotherapy within 4 weeks prior to study week 1.
7. Other immunotherapy within 4 weeks prior to study week 1.
8. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
9. Lack of availability for immunological and clinical follow-up assessment.
10. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
11. Pregnancy or breastfeeding.
12. Women of childbearing potential: refusal or inability to use effective means of contraception.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/01/2010
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 0 0
Austin Health (Ludwig Institute Oncology Unit) - Heidelberg
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Ludwig Institute for Cancer Research
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Austin Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Peter MacCallum Cancer Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan S Cebon, FRACP, MBBS, PhD
Address 0 0
Ludwig Institute for Cancer Research - Oncology Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data have been published
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT00518206