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| ID | Type | Description | Link |
|---|---|---|---|
| UCCRC-9372 | |||
| UCCRC-CTRC-9821 | |||
| NCI-G99-1615 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.
OBJECTIVES:
OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7, interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | CDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug |
|
| |
| dacarbazine |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 2 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
No uncontrolled brain metastases by CT scan
No clinically significant ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No significant thyroid dysfunction
No concurrent severe infection
No other medical or psychiatric condition that would interfere with compliance
No second malignancy within the past 5 years, except:
Suspected hearing deficits must undergo audiologic testing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas F. Gajewski, MD, PhD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D003606 | Dacarbazine |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Drug |
|
|
| Granulocyte-macrophage colony-stimulating factor | Drug |
|
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014226 |
| Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |