Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

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: NCT00014092
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: aldesleukin Biological: recombinant interferon alfa Biological: sargramostim Drug: temozolomide Phase 2

Detailed Description:


  • Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.
  • Determine the safety and tolerability of this regimen in this patient population.
  • Determine the changes in quality of life over time in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.

Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.

Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
Study Start Date : December 1999
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed unresectable stage IV melanoma
  • Measurable metastatic disease
  • No uncontrolled brain metastases



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN


  • BUN no greater than 1.5 times ULN
  • Creatinine no greater than 1.5 times ULN


  • No significant cardiovascular disease


  • No non-malignant systemic disease
  • No acute infection requiring IV antibiotics
  • No alcohol or substance abuse
  • No other condition, disease, or history of other illness that would preclude study participation
  • No hypersensitivity, allergic reactions, or intolerance to study drugs
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No prior interleukin-2
  • No other concurrent immunotherapy
  • No concurrent investigational vaccines or immunomodulatory agents
  • No other concurrent growth factors


  • At least 4 weeks since prior chemotherapy
  • No prior temozolomide
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No concurrent steroids (including corticosteroids)


  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics
  • At least 3 weeks since prior major surgery


  • At least 30 days since prior immune-based therapy
  • No concurrent participation in other clinical trials with investigational drugs
  • No other concurrent anticancer drugs
  • No concurrent immunosuppressive therapy
  • No concurrent levamisole or cimetidine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014092

United States, California
Saint Francis Memorial Hospital
San Francisco, California, United States, 94109
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
Saint Francis Memorial Hospital
Study Chair: Lynn E. Spitler, MD Northern California Melanoma Center at St. Francis Memorial Hospital

Publications of Results: Identifier: NCT00014092     History of Changes
Other Study ID Numbers: CDR0000067958
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: March 2004

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents