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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-95196 | Other Identifier | UT MD Anderson Cancer Center | |
| MDA-DM-95196 | Other Identifier | UT MD Anderson Cancer Center | |
| NCI-G96-1089 | |||
| CDR0000065188 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN-A Therapy Schedule A | Experimental | Schedule A: IV Interferon alfa-2b (IFN-A) induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks. |
|
| IFN-A Therapy Schedule B | Experimental | Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks. |
|
| Adjuvant Biochemotherapy | Experimental | Cisplatin IV Days 1-4; Vinblastine IVPB Days 1-4; Dacarbazine (DTIC) IVPB on Day 1; IFN-A is given subcutaneously on days 1-5; IL-2 continuous infusion for 96 hours on Days 1-4. Each course repeated every 21 days for 4 courses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldesleukin (IL-2) | Biological | Infusion for a total of 96 hours on days 1-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma | 1 year |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No serious intercurrent illness that would compromise tolerance of therapy and long term survival
Must be able to participate in follow up for minimum of 5 years
No second malignancy except:
Must be able to physically and emotionally tolerate biochemotherapy
No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Agop Y. Bedikian, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19430405 | Result | 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. doi: 10.1097/CMR.0b013e328314b84a. |
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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| Recombinant Interferon Alfa (IFN-A) | Biological | IFN-A Therapy Groups: Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks. Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5 |
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| Cisplatin | Drug | IV Days 1-4 |
|
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| Dacarbazine | Drug | IVPB on day 1 |
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| Vinblastine | Drug | IVPB on days 1-4 |
|
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| Adjuvant Therapy | Procedure | Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy. |
|
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D007376 | Interleukin-2 |
| D016898 | Interferon-alpha |
| D000077190 | Interferon alpha-2 |
| D002945 | Cisplatin |
| D003606 | Dacarbazine |
| D014747 | Vinblastine |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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