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High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 588 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Dec 2026 to May 26, 2026
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 41 of 533 sites
    • Study description shortened, about 4 words
  2. Study completion date: Dec 2025 to Dec 2026v587
  3. Study completion date: Oct 2025 to Dec 2025v586
  4. Re-verified, no change to tracked fieldsv585
  5. Start date: Dec 1998 to Mar 25, 1999v584
Show 45 earlier versionsHide 45 earlier versions
  1. 3 versions Re-verified since Jun 4, 2020, no change to tracked fieldsv581-v583
  2. Trial status: Terminated to Active, Not Recruiting
    • Site details revised at 2 of 533 sites
    v580
  3. Lead sponsor: Eastern Cooperative Oncology Group to ECOG-ACRIN Cancer Research Groupv579 Show 7 more changesShow less
    • Trial status: Suspended to Terminated
    • Results first posted: May 4, 2016
    • Primary completion date changed from estimate of Jul 2013 to Jan 2015
    • Sponsor's reason: The third interim analysis showed that there was no evidence of benefit from treatment with interferon.
    • Enrollment target: estimated 1420 to confirmed 1150
    • Study completion date: Oct 2025
    • Interventions: clinical observation (Other), recombinant interferon alfa (Biological) to interferon alfa-2b (Biological), observation (Other)
  4. Primary completion date: Dec 2014 to Jul 2013v578
  5. 2 versions Re-verified since Jun 4, 2011, no change to tracked fieldsv576-v577
  6. Trial status: Active, Not Recruiting to Suspendedv575
  7. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (533)
    v574
  8. Study sites: 514 to 533v573
  9. Study sites: 513 to 514v572
  10. Study sites: 533 to 513v571
  11. Study sites: 531 to 533v570
  12. Study sites: 522 to 531v569
  13. Site details revised at 1 of 522 sitesv568
  14. Study sites revised (522)v567
  15. Study sites: 523 to 522v566
  16. Study sites: 524 to 523v565
  17. Study sites: 525 to 524v564
  18. Study sites: 526 to 525v563
  19. Study sites: 535 to 526v562
  20. Study sites: 528 to 535v561
  21. Study sites revised (528)v560
  22. Study sites: 527 to 528v559
  23. Study sites: 528 to 527v558
  24. Study sites: 526 to 528v557
  25. Study sites: 527 to 526v556
  26. Study sites: 525 to 527v555
  27. Study sites: 526 to 525v554
  28. Study sites: 525 to 526v553
  29. Study sites: 527 to 525v552
  30. Study sites: 526 to 527v551
  31. Study sites: 528 to 526v550
  32. Study sites: 527 to 528v549
  33. Study sites: 528 to 527v548
  34. Study sites: 527 to 528v547
  35. Study sites: 529 to 527v546
  36. Study sites: 527 to 529v545
  37. Study sites: 526 to 527v544
  38. Study sites: 527 to 526v543
  39. Study sites: 530 to 527v542
  40. Site details revised at 1 of 530 sitesv541
  41. Study sites: 534 to 530v540
  42. Study sites: 533 to 534v539
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically. PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.
Trial Details
NCT Number NCT00003641
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI), SWOG Cancer Research Network, Cancer and Leukemia Group B, NCIC Clinical Trials Group, Children's Oncology Group
Conditions
(from sponsor)		 Melanoma (Skin)
Related terms Melanoma
Enrollment 1,150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov