- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014092
Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94109
- Saint Francis Memorial Hospital
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Santa Monica, California, United States, 90404
- John Wayne Cancer Institute at Saint John's Health Center
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Colorado
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Aurora, Colorado, United States, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable stage IV melanoma
- Measurable metastatic disease
- No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- 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
Renal:
- BUN no greater than 1.5 times ULN
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No significant cardiovascular disease
Other:
- 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
PRIOR CONCURRENT THERAPY:
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
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No prior temozolomide
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- No concurrent steroids (including corticosteroids)
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior major surgery
Other:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lynn E. Spitler, MD, Northern California Melanoma Center at St. Francis Memorial Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Interferons
- Interferon-alpha
- Aldesleukin
- Temozolomide
- Sargramostim
Other Study ID Numbers
- CDR0000067958
- SFMH-BB-IND-5301
- NCI-V00-1591
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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