Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Lynn E. Spitler, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Northern California Melanoma Center at St. Francis Memorial Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000067958
NCT ID:
NCT00014092
Start Date:
December 1999
Completion Date:
December 2003
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| John Wayne Cancer Institute at Saint John's Health Center | Santa Monica, California 90404 |
| Saint Francis Memorial Hospital | San Francisco, California 94109 |
