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3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors Clinical research trials and 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors. 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors clinical trial. Human subjects often get the best healthcare possible for their 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "3" Clinical Trials Conditions > 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors  3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors
3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help doxorubicin kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with doxorubicin in treating patients who have metastatic or refractorysolid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of 3-AP (Triapine^®) when administered with doxorubicin in patients with metastatic or refractory solid tumors. Secondary - Determine the toxicity profile of this regimen in these patients. - Determine any antitumor activity of this regimen in these patients. - Determine the pharmacokinetic profile of this regimen in these patients. OUTLINE: This is a dose-escalation study of 3-AP (Triapine^®). Patients receive doxorubicin IV over 3-5 minutes on day 1 and 3-AP (Triapine®) IV over 2 hours on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 3-AP (Triapine®) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 6 patients are treated at that dose level. Patients are followed until disease progression. PROJECTED ACCRUAL: A total of 3-36 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: - Histologically confirmed solid tumor - Metastatic or unresectable disease - Measurable or evaluable disease - Not amenable to available standard curative or palliative chemotherapy - No known brain metastasis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - WBC 3,000/mm^3 - No known G6PD deficiency Hepatic - AST/ALT 2.5 times upper limit of normal - Bilirubin normal Renal - Creatinine 1.5 mg/dL OR - Creatinine clearance 60 mL/min Cardiovascular - LVEF > 45% - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - Oxygen saturation 95-100% - No severe pulmonary disease requiring oxygen therapy Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 30 days after study treatment - No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP (Triapine®) or any other study agent - No other concurrent uncontrolled illness - No active or ongoing infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No prior anthracyclines Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 25% of bone marrow Surgery - Not specified Other - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeWilding, Study Chair, University of Wisconsin Comprehensive Cancer Center
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting George Wilding 608-263-8610
Additional Information:
Study ID Numbers: CDR0000353294; NCI-6266,WCCC-CO-03904
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079014
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. UCN-01 and Cisplatin in Treating Patients With Advanced Solid Tumors
2. E7070 in Treating Patients With Solid Tumors
3. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
4. Creatine in Treating Patients With Cancer-Associated Weight Loss
5. Combination Chemotherapy in Treating Patients With Advanced Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors
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