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Phase III Randomized Study of Postoperative GM2-KLH and QS21 Vaccination Versus Observation in Patients With Primary Cutaneous Stage II Melanoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Published Results Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Closed
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18 to 80
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Other
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EORTC-18961 BMS-CA152-003, NCT00005052
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Objectives - Compare the effect of immunization with GM2-KLH and QS21 to observation on the disease-free survival of patients with primary cutaneous stage II melanoma after adequate surgery.
- Determine overall survival and toxicity in the two treatment arms.
Entry 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
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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
- 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: 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
Expected Enrollment A total of 1300 patients (650 per arm) will be accrued for this study within
36 months. Outcomes Primary Outcome(s)Disease-free survival
Secondary Outcome(s)Duration of survival Toxicity as assessed by CTC v2
Outline This is a randomized, open-label, parallel, multicenter study. Patients
are stratified according to participating center, tumor thickness (greater
than 1.5 to 3.0 mm vs greater than 3.0 to 4.0 mm vs greater than 4.0 mm),
gender, ulceration (yes vs no), and presence of additional staging procedures
of regional lymph nodes (yes vs no). Patients are randomized to one of two
arms. - Arm I: Patients are vaccinated with GM2-KLH and QS21 subcutaneously on
day 1 of weeks 1-4, 12, 24, 36, 48, 60, 72, 84, 96, 120, and 144 for a total
of 14 vaccinations.
- Arm II: Patients undergo observation.
Patients are followed every 6 months for 7 years. Published ResultsEggermont AM, Suciu S, Ruka W, et al.: EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results. [Abstract] J Clin Oncol 26 (Suppl 15): A-9004, 2008.
Trial Contact Information
Trial Lead Organizations European Organization for Research and Treatment of Cancer | | | Alexander Eggermont, MD, PhD, Study coordinator | | | |
Registry Information | | Official 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 | | Trial Start Date | | 1999-12-20 | | Registered in ClinicalTrials.gov | | NCT00005052 | | Date Submitted to PDQ | | 2000-02-11 | | Information Last Verified | | 2006-01-05 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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