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| Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004196 |
Purpose
RATIONALE: Interferon alfa-2b may interfere with the growth of cancer cells.
PURPOSE: Randomized phase III trial to study the effectiveness of interferon alfa-2b in treating patients who have melanoma with early lymph node metastasis.
| Condition | Intervention | Phase |
|
Melanoma (Skin) |
Drug: recombinant interferon alfa Procedure: adjuvant therapy Procedure: conventional surgery Procedure: lymphangiography Procedure: polymerase chain reaction Procedure: radionuclide imaging Procedure: reverse transcriptase-polymerase chain reaction Procedure: sentinel lymph node biopsy |
Phase III |
| MedlinePlus related topics: | Cancer Melanoma Nuclear Scans |
| Drug Information available for: | Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Multicenter Trial of Adjuvant Interferon Alfa-2b for Melanoma Patients With Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy |
| Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients in the randomized portions of Protocols A and B are stratified according to tumor thickness (1-2 mm vs 3-4 mm vs greater than 4 mm) and tumor ulceration (yes vs no).
All patients undergo wide local tumor excision with lymphatic mapping and sentinel node biopsy. Patients with tumors with ambiguous drainage patterns undergo lymphoscintigraphy prior to tumor excision. Patients with evidence of metastatic melanoma in the sentinel node(s) by routine histology, serial sectioning, or immunohistochemistry and who have undergone a prior regional lymph node dissection proceed to protocol A.
Protocol A: Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms.
Patients with no evidence of sentinel node(s) metastases by routine histology, serial sectioning, and immunohistochemistry and are negative by polymerase chain reaction (PCR) analysis are observed.
Protocol B: Patients with positive sentinel node(s) by PCR analysis are randomized to one of three treatment arms.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 5 years.
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive cutaneous melanoma
Protocol A:
Protocol B:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Alabama | |||||
| University of Alabama at Birmingham Comprehensive Cancer Center | |||||
| Birmingham, Alabama, United States, 35294-3300 | |||||
| United States, Kentucky | |||||
| James Graham Brown Cancer Center at University of Louisville | |||||
| Louisville, Kentucky, United States, 40202 | |||||
| United States, New Jersey | |||||
| Cancer Institute of New Jersey | |||||
| New Brunswick, New Jersey, United States, 08903 | |||||
| United States, New York | |||||
| Roswell Park Cancer Institute | |||||
| Buffalo, New York, United States, 14263-0001 | |||||
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
| National Cancer Institute (NCI) |
| Study Chair: | Marshall M. Urist, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067439, UAB-9735, UAB-F970925009, NCI-G99-1654, RPCI-DS-99-14 |
| First Received: | January 21, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004196 |
| Health Authority: | United States: Federal Government |
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