Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
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
NCT00005052CI-TRIAL-00002032unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| GM2-KLH vaccine | Biological | — | UNRESOLVED |
| QS21 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival
Secondary outcomes (2)
- measure
- Duration of survival
- measure
- Toxicity as assessed by CTC v2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTEggermont 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.
- DERIVEDPatel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18. PMID 21600759