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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | October 29, 2009 | ||||
| Start Date ICMJE | November 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00002882 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma | ||||
| Official Title ICMJE | ADJUVANT THERAPY FOR MELANOMA PATIENTS WITH REGIONAL LYMPH NODE METASTASES WITH INTERFERON ALFA-2B VS. BIOCHEMOTHERAPY USING CISPLATIN + VINBLASTINE + DTIC + INTERFERON PLUS IL-2 | ||||
| Brief Summary | RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized study. All patients are stratified according to prognostic factors. Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy. Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules.
PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||
| Condition ICMJE | Melanoma (Skin) | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Kim KB, Legha SS, Gonzalez R, Anderson CM, Johnson MM, Liu P, Papadopoulos NE, Eton O, Plager C, Buzaid AC, Prieto VG, Hwu WJ, Frost AM, Alvarado G, Hwu P, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, Benjamin RS, Bedikian AY. A randomized phase III trial of biochemotherapy versus interferon-alpha-2b for adjuvant therapy in patients at high risk for melanoma recurrence. Melanoma Res. 2009 Feb;19(1):42-9. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 10 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002882 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065188, MDA-ID-95196, MDA-DM-95196, NCI-G96-1089 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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