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3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors conditions. Clinical Trials Search.org is a site devoted 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 healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms 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 allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors clinical trial. Test subjects oftentimes recieve the best healthcare possible for their 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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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. SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors
2. Bizelesin in Treating Patients With Advanced Cancer
3. Evaluating Patient Participation in Phase I Clinical Trials
4. Chemotherapy in Treating Patients With Advanced Solid Tumors
5. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Arizona Clinical Trials
Other Tucson Clinical Trials
3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
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