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Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Gajewski, University of Chicago
ClinicalTrials.gov Identifier:
NCT00004141
First received: December 10, 1999
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  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)
 Drug: Cisplatin
Drug: dacarbazine
Drug: Granulocyte-macrophage colony-stimulating factor
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: August 1998
Study Completion Date: April 2006
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: CDDP
Drug: dacarbazine
Other Name: DTIC
Drug: Granulocyte-macrophage colony-stimulating factor
Other Name: GM-CSF

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
National Cancer Institute (NCI)
Investigators
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Thomas Gajewski, Associate Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00004141     History of Changes
Other Study ID Numbers: 9372, UCCRC-9372, UCCRC-CTRC-9821, NCI-G99-1615
Study First Received: December 10, 1999
Last Updated: February 14, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cisplatin
 Dacarbazine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013