Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma
Cisplatin
+ dacarbazine
+ Granulocyte-macrophage colony-stimulating factor
Neoplasms+9
+ Neoplasms by Histologic Type
+ Neoplasms by Site
Treatment Study
Summary
Study start date: August 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.46 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Chicago Cancer Research Center
Chicago, United StatesOpen University of Chicago Cancer Research Center in Google Maps