At a glance
ClinicalIndex Comparison Record- ✓Histologically proven cutaneous melanoma or melanoma of unknown primary
- ✓High-risk disease defined by one of: ulcerated primary with ≥1 involved lymph nodes, non-ulcerated/unknown primary with ≥1 macro nodal involvement, non-ulcerated melanoma with ≥2 lymph node metastases, or any satellite/in-transit metastasis
- ✓Disease-free status at enrollment with negative surgical margins and complete lymphadenectomy
- ✓Lymphadenectomy or recurrent disease surgery within 56 days of enrollment
- ✕Distant metastases present
- ✕Ocular, mucosal, or other non-cutaneous origin melanoma
- ✕Non-ulcerated or unknown primary melanoma with single micrometastatic lymph node only
- ✕Recurrent disease not in regional nodal basin of prior complete lymphadenectomy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma
In Brief
A Phase 3 clinical trial evaluating interleukin-2, filgrastim, and 4 other interventions for Melanoma (Skin). Completed, enrolled 432 participants across 297 sites in 2 countries.
Detailed Summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.
Study Details
Timeline
Interventions
Given IV
Given subcutaneously
Given IV and subcutaneously
Given IV
Given IV
Given IV