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Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma Clinical research trials and Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma  Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
For Condition: stage 3 melanoma,Recurrent Melanoma,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasGajewski, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Additional Information:
Study ID Numbers: CDR0000067372; UCCRC-9372,UCCRC-CTRC-9821,NCI-G99-1615
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004141
Other Recurrent Melanoma Studies:
1. Imatinib Mesylate in Treating Patients With Metastatic Melanoma
2. CCI-779 in Treating Patients With Metastatic Melanoma
3. O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma
4. Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma
5. Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
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