Phase II Randomized Study of Postoperative Adjuvant Therapy with Alpha-2 Recombinant Interferon vs No Adjuvant Therapy in Adults with Stage I/II Melanoma
Basic Trial Information
|Phase II||Treatment||Completed||18 to physiologic 70||NCI||EST-1684|
I. Determine, in a randomized Phase II study, the efficacy of alpha-2 recombinant interferon as postoperative adjuvant therapy in patients with Stage II melanoma who, after surgery, have no evidence of disease but who are at high risk for recurrence by determining overall survival, disease-free interval, and site of relapse.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients between the physiologic ages of 18 and 70 years with histologically confirmed primary melanoma of clinical Stage I or II; all patients must receive a full lymphadenectomy and must be found to have either pathologic Stage I disease with a Breslow depth exceeding 4 mm or pathologic Stage II disease. For patients entered at initial presentation, there must be pathologic evidence of adequate margins around the primary lesion (at least 3 cm) and a full lymphadenectomy (total number of negative and positive nodes at least 15 for head and neck lesions, at least 10 for upper extremity lesions, and at least 5 for lower extremity lesions). Patients with regional node recurrences will also be required to have appropriate lymphadenectomy. Both superficial and deep inguinal node dissections will be required for palpable recurrence in the groin. Patients entered with lymph node recurrence must also have adequate surgical margins; if the site of lymph node recurrence has previously been operated, the requirement for number of negative and positive nodes will be waived. Patients who are treated at initial presentation must have had definitive surgery within 28 days of initial biopsy, and randomization must occur no more than 56 days following initial biopsy. Patients treated for recurrent Stage II lymph node disease must be within 42 days of lymphadenectomy. The ECOG performance status must be 0 or 1, and there must be evidence of adequate bone marrow, liver, and kidney function. Patients who are surgically staged for midline truncal or head and neck lesions that have ambiguous drainage (or multiple potential sites of lymphatic drainage) will be eligible as surgically staged individuals only if lymphoscintigram documents drainage solely or predominantly to a single operable lymph node group that has been resected. Patients eligible for the intergroup surgical trial (EST-1683) must be placed preferentially into that study and are ineligible subsequently for this study. There may be no second malignancy except for in situ cervical cancer or basal or squamous skin cancer (exceptions may be discussed with the Study Chairman), and patients may not have any major medical illness requiring ongoing chronic therapy or any ongoing infection requiring antibiotic treatment. There may be no history of ventricular arrhythmia, supraventricular tachycardia requiring treatment, cardiac failure (New York Heart Association class greater than 2), or any prior anthracycline treatment. Patients must be free from organic brain syndrome and significant impairment of basal cognitive function. Patients may not be concurrently taking steroids, nonsteroidal anti-inflammatory drugs, or other prostaglandin synthetase inhibitors, antihistamines, or other known immunomodulators. There may have been no prior adjuvant radiotherapy, chemotherapy, or immunotherapy, and patients with recurrent melanoma must not have been previously entered in this study.
As of January 1989, the accrual goal was 285 patients; it was anticipated that the goal would be reached in about 12 months.
Randomized study. Arm I: Adjuvant Immunotherapy. Alpha-2 Recombinant Interferon, IFN, NSC-377523. Arm II: No adjuvant therapy.
Chiarion-Sileni V, Romanini A, Tanganelli L, et al.: Interferon alpha 2b (IFN) according to ECOG EST 1684 protocol in high risk melanoma patients (PTS): the Italian experience. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1999, 520a, 1998.
Kirkwood JM, Resnick GD, Cole BF: Efficacy, safety, and risk-benefit analysis of adjuvant interferon alfa-2b in melanoma. Semin Oncol 24 (1 Suppl 4): S16-23, 1997.[PUBMED Abstract]
Cole BF, Gelber RD, Kirkwood JM, et al.: Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: an Eastern Cooperative Oncology Group study. J Clin Oncol 14 (10): 2666-73, 1996.[PUBMED Abstract]
Kirkwood JM, Strawderman MH, Ernstoff MS, et al.: Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684. J Clin Oncol 14 (1): 7-17, 1996.[PUBMED Abstract]
Kirkwood J, Hunt M, Smith T, et al.: A randomized controlled trial of high-dose IFN alfa-2b for high-risk melanoma: the ECOG trial EST-1684. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-1331, 390, 1993.
Kirkwood J, Hunt M, Smith T, et al.: A randomized controlled trial of high-dose IFN alfa-2b for high-risk melanoma: the ECOG trial EST-1684. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-1331, 1993.
Ibrahim JG, Chen MH, Chu H: Bayesian methods in clinical trials: a Bayesian analysis of ECOG trials E1684 and E1690. BMC Med Res Methodol 12: 183, 2012.[PUBMED Abstract]
Kilbridge KL, Cole BF, Kirkwood JM, et al.: Quality-of-life-adjusted survival analysis of high-dose adjuvant interferon alpha-2b for high-risk melanoma patients using intergroup clinical trial data. J Clin Oncol 20 (5): 1311-8, 2002.[PUBMED Abstract]
Kilbridge KL, Cole B, Weeks JC, et al.: Quality-of-life (QOL) adjusted analysis of high-dose adjuvant interferon alfa-2B (HDI) for melanoma based on E1694/S9512/C509801, E1690/S9111/C9190 and E1684. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1398, 2002.
Agarwala SS, Kirkwood JM: Adjuvant therapy of melanoma. Semin Surg Oncol 14 (4): 302-10, 1998.[PUBMED Abstract]
Hillner BE, Kirkwood JM, Atkins MB, et al.: Economic analysis of adjuvant interferon alfa-2b in high-risk melanoma based on projections from Eastern Cooperative Oncology Group 1684. J Clin Oncol 15 (6): 2351-8, 1997.[PUBMED Abstract]
Hillner B, Kirkwood JM, Atkins MB, et al.: Economic analysis of adjuvant interferon-alpha 2b (IFN) in high risk melanoma using projections from ECOG (E1684). [Abstract] Proceedings of the American Society of Clinical Oncology 16: A1469, 411a, 1997.
Trial Contact Information
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.