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3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With 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-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors Clinical research trials and 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With 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-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors. 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With 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-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors clinical trial. Human subjects often get the best healthcare possible for their 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With 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-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors  3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Vion Pharmaceuticals ,
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 3-aminopyridine-2-carboxaldehyde thiosemicarbazone in treating patients who have solid tumors that have not responded to previous treatment.
Details: OBJECTIVES: I. Determine the effects of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) in patients with solid tumors by evaluating the safety and tolerability, maximum tolerated dose (MTD) and recommended dose for Phase II studies, pharmacokinetics, and tumor response. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) IV over 2 hours on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of 3-AP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for 4 weeks or until recovered. PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignant solid tumor that has failed 1 or more conventional treatments or is unlikely to respond to currently available therapies - No active CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Prior growth factor treatment allowed if blood counts normal - Chemotherapy: At least 3 weeks since prior chemotherapy and recovered; At least 6 weeks since prior nitrosoureas or mitomycin and recovered; Prior hydroxyurea allowed and recovered - Endocrine therapy: At least 2 weeks since prior hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No prior radiotherapy to greater than 30% of the bone marrow - Surgery: At least 2 weeks since any prior major surgery - Other: At least 4 weeks since other prior investigational agents and recovered; No other concurrent investigational agents without consent of sponsor --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 3 months - Hematopoietic: WBC greater than 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 2.0 mg/dL; AST and ALT no greater than 3 times upper limit of normal (ULN); Alkaline phosphate no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) - Renal: Creatinine less than 2.0 mg/dL - Cardiovascular: No myocardial infarction within the past 3 months; No symptomatic coronary artery disease or heart block; No uncontrolled congestive heart failure - Pulmonary: No moderate or severe pulmonary dysfunction - Other: Not pregnant or nursing; Negative pregnancy test; Fertile women must use effective contraception; Body weight greater than 50 kg; No active infection; No mental deficits and/or psychiatric disorders that would preclude study; No other life-threatening illness; No bleeding disorder (except occult blood from gastrointestinal cancer)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Additional Information:
Study ID Numbers: CDR0000067390; VION-CLI-001-2,NCI-V99-1579
Study Start Date: May 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004213
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
2. Bupropion and Counseling With or Without Contigency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
3. Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
4. LY293111 in Treating Patients With Advanced Solid Tumors
5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
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