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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00005052




Registration number
NCT00005052
Ethics application status
Date submitted
6/04/2000
Date registered
27/01/2003
Date last updated
9/02/2009

Titles & IDs
Public title
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Scientific title
Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation
Secondary ID [1] 0 0
EORTC-18961
Secondary ID [2] 0 0
CDR0000067645
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GM2-KLH vaccine
Other interventions - QS21
Treatment: Surgery - adjuvant therapy

Other interventions: GM2-KLH vaccine


Other interventions: QS21


Treatment: Surgery: adjuvant therapy


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Duration of survival
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Toxicity as assessed by CTC v2
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed primary stage II melanoma greater than 1.5 mm without
evidence of lymph node metastases

- T3 or T4, N0, M0

- Must originate in the skin

- Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy
scar

- No more than 56 days since definitive surgical treatment (wide excision)

- No more than 12 weeks since primary surgery

- No clinical, radiological, or pathological evidence of incompletely resected disease,
lymph node metastases, in-transit metastasis, or any distant metastatic disease

PATIENT CHARACTERISTICS:

Age:

- 18 to 80

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.8 g/dL

Hepatic:

- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

- LDH no greater than 2 times ULN

- Bilirubin no greater than 2 times ULN

- Hepatitis B and C negative

Renal:

- Creatinine normal

Other:

- Not pregnant or nursing

- Negative pregnancy test

- No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or
squamous cell skin cancer

- No autoimmune disorders

- No conditions requiring systemic treatment with immunosuppressive drugs including
treatment with systemic corticosteroids

- No history of CNS demyelinating or inflammatory disease

- No hereditary or acquired peripheral neuropathy

- No other significant medical or surgical condition or psychiatric disorders requiring
medication that would preclude study

- No history of severe allergic reaction to shellfish

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy

- No other concurrent biologic therapy

Chemotherapy:

- No prior systemic chemotherapy

- No concurrent cytotoxic chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except replacement therapy

- No concurrent corticosteroids

- No concurrent chronic systemic steroids

Radiotherapy:

- No prior adjuvant radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No prior preoperative infusion or perfusion therapy

- No concurrent immunosuppressive medications

- No other concurrent anticancer therapy
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Belgium
State/province [3] 0 0
Ghent
Country [4] 0 0
Belgium
State/province [4] 0 0
Haine Saint Paul
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Denmark
State/province [6] 0 0
Aarhus
Country [7] 0 0
Denmark
State/province [7] 0 0
Copenhagen
Country [8] 0 0
Denmark
State/province [8] 0 0
Odense
Country [9] 0 0
Estonia
State/province [9] 0 0
Tallinn
Country [10] 0 0
Finland
State/province [10] 0 0
Tampere
Country [11] 0 0
France
State/province [11] 0 0
Besancon
Country [12] 0 0
France
State/province [12] 0 0
Boulogne Billancourt
Country [13] 0 0
France
State/province [13] 0 0
Caen
Country [14] 0 0
France
State/province [14] 0 0
Clermont-Ferrand
Country [15] 0 0
France
State/province [15] 0 0
Lille
Country [16] 0 0
France
State/province [16] 0 0
Montpellier
Country [17] 0 0
France
State/province [17] 0 0
Nice
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Rennes
Country [20] 0 0
France
State/province [20] 0 0
Thionville
Country [21] 0 0
France
State/province [21] 0 0
Vandoeuvre-les-Nancy
Country [22] 0 0
France
State/province [22] 0 0
Villejuif
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Wuerzburg
Country [25] 0 0
Israel
State/province [25] 0 0
Haifa
Country [26] 0 0
Israel
State/province [26] 0 0
Holon
Country [27] 0 0
Italy
State/province [27] 0 0
Aviano
Country [28] 0 0
Italy
State/province [28] 0 0
Firenze
Country [29] 0 0
Italy
State/province [29] 0 0
Genoa (Genova)
Country [30] 0 0
Italy
State/province [30] 0 0
Milano (Milan)
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Naples
Country [33] 0 0
Italy
State/province [33] 0 0
Padova
Country [34] 0 0
Italy
State/province [34] 0 0
Rome
Country [35] 0 0
Italy
State/province [35] 0 0
Torino
Country [36] 0 0
Netherlands
State/province [36] 0 0
Leiden
Country [37] 0 0
Netherlands
State/province [37] 0 0
Nijmegen
Country [38] 0 0
Netherlands
State/province [38] 0 0
Rotterdam
Country [39] 0 0
Norway
State/province [39] 0 0
Oslo
Country [40] 0 0
Poland
State/province [40] 0 0
Poznan
Country [41] 0 0
Poland
State/province [41] 0 0
Warsaw
Country [42] 0 0
Portugal
State/province [42] 0 0
Porto
Country [43] 0 0
Portugal
State/province [43] 0 0
Santarem
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Moscow
Country [45] 0 0
Serbia
State/province [45] 0 0
Belgrade
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Zaragoza
Country [48] 0 0
Switzerland
State/province [48] 0 0
Lausanne
Country [49] 0 0
United Kingdom
State/province [49] 0 0
England
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Scotland
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Wales
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not
yet known whether vaccine therapy is more effective than observation alone for melanoma.

PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works
compared to observation alone in treating patients with primary stage II melanoma.
Trial website
https://clinicaltrials.gov/show/NCT00005052
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexander M. M. Eggermont, MD, PhD
Address 0 0
Daniel Den Hoed Cancer Center at Erasmus Medical Center
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00005052