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Home > "D" Clinical Trials Conditions > Decitabine in Treating Patients With Advanced Solid Tumors  Decitabine in Treating Patients With Advanced Solid Tumors
Decitabine in Treating Patients With Advanced Solid Tumors
For Condition: Male Breast Cancer,Breast Cancer,Melanoma,Bladder Cancer,adult solid tumor
Status: Recruiting
Sponsor(s): University of Southern California , 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. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have advanced solid tumors that have not responded to previous treatment.
Details: OBJECTIVES: - Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors. - Determine the toxic effects of this drug in these patients. - Determine the dose of this drug with biologic activity in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine clinical response to this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to: - Stage III or IV melanoma - Mucosal melanoma allowed - Resectable stage III melanoma not allowed - Bladder cancer - Breast cancer - At least 2 cutaneous, mucosal, or lymph nodal lesions that can be biopsied OR 1 lesion large enough to be biopsied twice by large bore needle or excisional biopsy - No active symptomatic CNS disease - No radiographically evident cerebral edema - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Hemoglobin at least 9.0 g/dL - Platelet count at least 100,000/mm^3 - WBC at least 3,500/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - No coagulation disorders Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT and SGPT less than 2.5 times ULN - Hepatitis B surface antigen negative - Hepatitis C antibody negative Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No major cardiovascular system illness Pulmonary: - No major respiratory system illness Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No major systemic infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - At least 1 month since prior radiotherapy Surgery: - Not specified Other: - At least 1 month since any prior anticancer therapy or adjuvant therapy - No other experimental treatment within 30 days prior to, during, and for 30 days after study therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyWeber, Study Chair, University of Southern California
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Primo Lara 916-734-3771
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90089
United States
Recruiting Jeffrey Weber 323-865-3360
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Lucille Leong 626-359-8111
Additional Information:
Study ID Numbers: CDR0000069182; LAC-USC-0C0101,NCI-5353
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030615
Other Male Breast Cancer Studies:
1. Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
2. Decitabine in Treating Patients With Advanced Solid Tumors
3. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma
4. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
5. Docetaxel in Treating Patients With Solid Tumors
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Decitabine in Treating Patients With Advanced Solid Tumors
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