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O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma Clinical research trials and O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma. O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma  O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma
O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma,stage 3 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. Combining more than once chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine and carmustine in treating patients who have unresectable locally recurrent or metastatic melanoma.
Details: OBJECTIVES: - Determine the objective clinical response rate and duration of response in patients with unresectable locally recurrent or metastatic melanoma treated with O6-benzylguanine and carmustine. - Compare the toxicities of this regimen in patients with no prior chemotherapy vs prior chemotherapy failure. - Correlate clinical response to this regimen in these patients with O6-alkylguanine DNA alkyltransferase (AGT) depletion and baseline AGT in peripheral blood mononuclear cells and tumor tissue. OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (chemotherapy failure vs chemotherapy naive). Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV over 1 hour on day 1. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression are followed every 6 months. All other patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 24-41 patients will be accrued for the chemotherapy failure stratum and a total of 18-35 patients will be accrued for the chemotherapy naive stratum of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven unresectable locally recurrent or metastatic melanoma - Chemotherapy naive with no more than 2 prior immunotherapy regimens (including cytokines, vaccines, or adjuvant interferon) OR - Prior chemotherapy failure with no more than 2 prior immunotherapy regimens (including adjuvant interferon) and no more than 1 prior chemotherapy regimen (which may include carmustine) not including antiangiogenesis therapy - Measurable disease - At least 20 mm in at least 1 dimension by conventional technique OR at least 10 mm in at least 1 dimension by spiral CT scan - No disease confined only to the CNS - No uncontrolled symptomatic brain metastases regardless of other disease sites PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,200/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST and/or ALT no greater than 3 times upper limit of normal - PT normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Pulmonary: - DLCO at least 70% predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No concurrent significant psychiatric or medical illness, including active infections, that would interfere with study therapy or increase risk - No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior systemic chemotherapy (at least 6 weeks since prior carmustine or mitomycin) and recovered - No other concurrent chemotherapy or investigational antineoplastic drugs Endocrine therapy: - Not specified Radiotherapy: - At least 2 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - At least 3 weeks since prior major surgery and recovered Other: - At least 4 weeks since other prior anticancer systemic therapy and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasGajewski, Study Chair, University of Chicago Cancer Research Center
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Mercy Ireland Cancer Center
Canton, Ohio, 44708
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000067943; UCCRC-10325,NCI-T99-0111,CWRU-1699
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005961
Other Stage 4 Melanoma Studies:
1. Surgery in Treating Patients With Metastatic Melanoma
2. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
3. Biological Therapy in Treating Patients With Metastatic Melanoma
4. Vaccine Therapy in Treating Patients With Stage IV Melanoma
5. Combination Chemotherapy, Interferon alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Ohio Clinical Trials
Other Canton Clinical Trials
O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma
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