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Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004141
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: recombinant interferon alfa
Biological: sargramostim
Drug: cisplatin
Drug: dacarbazine
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Cisplatin Interferon alfa-2a Granulocyte-macrophage colony-stimulating factor Aldesleukin Sargramostim Interferon alfa-n1 Dacarbazine Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1998
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 10 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No clinically significant pulmonary disease on chest x-ray

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:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

  • At least 2 weeks since prior radiotherapy

Surgery:

  • At least 3 weeks since major surgery

Other:

  • No concurrent immunosuppressive drugs
  • No other concurrent investigational antineoplastic drugs
  • Concurrent thyroid replacement therapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004141

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067372, UCCRC-9372, UCCRC-CTRC-9821, NCI-G99-1615
Study First Received: December 10, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004141     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Anti-HIV Agents
Dacarbazine
Immunologic Factors
Interferons
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Aldesleukin
Anti-Retroviral Agents
Cisplatin
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Antineoplastic Agents, Alkylating
Nevus
Interferon Alfa-2a
Alkylating Agents

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Anti-Retroviral Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Angiogenesis Modulating Agents
Growth Inhibitors
Alkylating Agents
Interferon-alpha
Anti-HIV Agents
Neoplasms by Histologic Type
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Antineoplastic Agents, Alkylating
Interferon Alfa-2a

ClinicalTrials.gov processed this record on May 07, 2009