Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Melanoma (Skin)	Biological: GM2-KLH vaccine; Biological: QS21; Procedure: adjuvant therapy	Phase 3

Detailed Description:

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.

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.

PROJECTED ACCRUAL: A total of 1300 patients (650 per arm) will be accrued for this study within 36 months.

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	December 1999

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Disease-free survival

Secondary Outcome Measures :

1. Duration of survival
2. Toxicity as assessed by CTC v2

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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  Show 80 Study Locations

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

OverallOfficial:	Alexander M. M. Eggermont, MD, PhD	Daniel Den Hoed Cancer Center at Erasmus Medical Center

More Information

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Publications of Results:

Eggermont 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Patel 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.

ClinicalTrials.gov Identifier:	NCT00005052 History of Changes
Other Study ID Numbers:	CDR0000067645; EORTC-18961; BMS-CA152-003
First Posted:	January 27, 2003
Last Update Posted:	February 9, 2009
Last Verified:	January 2006

Keywords provided by National Cancer Institute (NCI):

stage II melanoma

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue	Nevi and Melanomas; Vaccines; QS 21; Immunologic Factors; Physiological Effects of Drugs; Adjuvants, Immunologic