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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
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EORTC-18961
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Secondary ID [2]
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CDR0000067645
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin)
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-free survival
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Duration of survival
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Timepoint [1]
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Secondary outcome [2]
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Toxicity as assessed by CTC v2
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Assessment method [2]
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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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Intervention assignment
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/1999
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Date of last participant enrolment
Anticipated
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Actual
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Anticipated
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Actual
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Sample size
Target
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Belgium
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Brussels
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Belgium
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Edegem
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Ghent
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Haine Saint Paul
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Israel
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Holon
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United Kingdom
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Birmingham
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Funding & Sponsors
Primary sponsor type
Other
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Name
European Organisation for Research and Treatment of Cancer - EORTC
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00005052
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alexander M. M. Eggermont, MD, PhD
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Address
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Daniel Den Hoed Cancer Center at Erasmus Medical Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00005052
Download to PDF