Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004141
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

December 10, 1999
January 27, 2003
September 5, 2013
August 1998
January 2003   (Final data collection date for primary outcome measure)
Objective response rate [ Time Frame: 2 years ]
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Complete list of historical versions of study NCT00004141 on Archive Site
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Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma

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.


  • Determine the toxicity of cisplatin and dacarbazine followed by sargramostim (GM-CSF), interferon alfa, and interleukin-2 in patients with metastatic melanoma.
  • Determine the objective response rate, relapse free survival, and overall survival of these patients on this regimen.

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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Melanoma (Skin)
  • Drug: Cisplatin
    Other Name: CDDP
  • Drug: dacarbazine
    Other Name: DTIC
  • Drug: Granulocyte-macrophage colony-stimulating factor
    Other Name: GM-CSF
Experimental: Arm A
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.
  • Drug: Cisplatin
  • Drug: dacarbazine
  • Drug: Granulocyte-macrophage colony-stimulating factor
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2006
January 2003   (Final data collection date for primary outcome measure)


  • Histologically confirmed metastatic melanoma

    • Stage III with intransit metastases
    • Stage IV
  • No uncontrolled brain metastases by CT scan
  • No clinically significant ascites or pleural effusions



  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 10 weeks


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.5 g/dL


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT no greater than 4 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 70 mL/min


  • No clinically significant cardiac disease on EKG, echocardiogram, or MUGA scan


  • No clinically significant pulmonary disease on chest x-ray


  • 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:

    • Localized nonmelanomatous skin cancer
    • Carcinoma in situ of the cervix
    • Grade 1 Ta bladder cancer
  • Suspected hearing deficits must undergo audiologic testing


Biologic therapy:

  • No more than one prior immunotherapy regimen
  • At least 4 weeks since prior immunotherapy
  • Adjuvant interferon alfa before relapse allowed


  • No more than one prior chemotherapy regimen
  • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
  • No concurrent cyclophosphamide
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids or cyclosporine A


  • At least 2 weeks since prior radiotherapy


  • At least 3 weeks since major surgery


  • No concurrent immunosuppressive drugs
  • No other concurrent investigational antineoplastic drugs
  • Concurrent thyroid replacement therapy allowed
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
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University of Chicago
University of Chicago
National Cancer Institute (NCI)
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP