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Phase II Randomized Study of Vaccination with GM-2 Ganglioside Conjugated to Keyhole Limpet Hemocyanin plus the Immunologic Adjuvant QS21 with vs without High-Dose Interferon alfa in High-Risk Melanoma
Basic Trial Information
Objectives I. Determine the effect of high-dose interferon alfa (IFN-A) on anti-GM2 antibody response when administered during or after vaccination with GM-2 ganglioside covalently conjugated to keyhole limpet hemocyanin (KLH) plus the immunologic adjuvant QS21 (GM2-KLH/QS21) in patients with resected melanoma at high risk of recurrence. II. Assess the toxic effects of GM2-KLH/QS21 when administered with high-dose IFN-A. Entry Criteria Disease Characteristics: Histologically confirmed malignant melanoma in 1 of the following categories: Newly diagnosed primary stage II disease that is greater than 4 mm deep Stage III/IV disease Skin or subcutaneous lesions beyond site of drainage (M1a) Solitary resectable meastases involving visceral organs (M1b) and now disease free First clinically detected nodal recurrence Entry required within 365 days of complete resection rendering patient clinically free of disease Negative abdominothoracic CT required of patients with M1 disease Patient must be ineligible for protocol E-1694 Prior/Concurrent Therapy: Recovered from all prior therapy Biologic therapy: No prior immunotherapy, e.g.: Tumor vaccines Interferons Interleukins Levamisole Other biological response modifiers Chemotherapy: No prior chemotherapy (including infusion or perfusion therapy) Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior radiotherapy to intact lymph node basins Surgery: See Disease Characteristics Other: At least 2 weeks since systemic anti-inflammatory drugs, antihistamines, or corticosteroids and not expected to require such therapy Patient Characteristics: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than twice normal AST no greater than twice normal Alkaline phosphatase and LDH normal (negative contrast-enhanced liver CT or MRI required if elevated) Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No cardiac arrhythmias requiring therapy No history of congestive heart failure No history of ischemic heart disease (NYHA class III/IV status) Other: No active infection requiring antimicrobial drugs No active bleeding No severe allergy to shellfish No autoimmune disorder or immunosuppressive condition, including splenectomy No organic brain syndrome or significant impairment of basal cognitive function No CNS-demyelinating, inflammatory disease, or hereditary or acquired peripheral neuropathy No psychiatric or medical condition contraindicating protocol participation No second malignancy within 5 years except: Nonmelanomatous skin cancer In situ lobular carcinoma of the breast In situ cervical carcinoma Atypical melanocytic hyperplasia or Clark I melanoma in situ No pregnant or nursing women Negative pregnancy test required within 2 weeks prior to entry Effective contraception required of fertile patients throughout study and for 18 months thereafter Expected Enrollment A total of 140 patients will be accrued over 1-1.2 years. Outcomes Primary Outcome(s)Effect of high-dose IFN-A on anti-GM2 antibody response Outline Randomized study. The following acronyms are used: GM2-KLH Ganglioside GM-2 conjugated to Keyhole Limpet Hemocyanin IFN-A Interferon alfa (Schering), NSC-377523 QS21 Immunologic Adjuvant QS21, NSC-679689 Arm I: Biological Response Modifier Therapy. GM2-KLH/QS21; with IFN-A (beginning with vaccine therapy). Arm II: Biological Response Modifier Therapy. GM2-KLH/QS21; with IFN-A (beginning after vaccine therapy). Arm III: Vaccine Therapy. GM2-KLH/QS21.Published Results Stuckert JJ, Tarhini AA, Lee S, et al.: Interferon alfa-induced autoimmunity and serum S100 levels as predictive and prognostic biomarkers in high-risk melanoma in the ECOG-intergroup phase II trial E2696. [Abstract] J Clin Oncol 25 (Suppl 18): A-8506, 473s, 2007. Stuckert JJ II, Tarhini A, Lee S, et al.: Interferon alfa-induced autoimmunity in patients with high-risk melanoma participating in ECOG phase II trial E2696. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-166, 2007. Tarhini AA, Stuckert J, Lee S, et al.: Prognostic significance of serial serum S100 protein levels in high-risk surgically resected melanoma in ECOG phase II trial E2696. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-2437, 2007. Kirkwood JM, Ibrahim J, Lawson DH, et al.: High-dose interferon alfa-2b does not diminish antibody response to GM2 vaccination in patients with resected melanoma: results of the Multicenter Eastern Cooperative Oncology Group Phase II Trial E2696. J Clin Oncol 19 (5): 1430-6, 2001.[PUBMED Abstract] Chapman P, Morrissey D, Ibrahim J, et al.: Eastern Cooperative Oncology Group phase II randomized adjuvant trial of GM2-KHL+(GMK) vaccine plus/minus high dose interferon-a2b (HD IFN) in melanoma (MEL). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2078, 538a, 1999. Trial Lead Organizations Eastern Cooperative Oncology Group
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. |
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