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VNP20009 in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on VNP20009 in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. VNP20009 in Treating Patients With Advanced Solid Tumors Clinical research trials and VNP20009 in Treating Patients With Advanced Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like VNP20009 in Treating Patients With Advanced Solid Tumors. VNP20009 in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a VNP20009 in Treating Patients With Advanced Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their VNP20009 in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > VNP20009 in Treating Patients With Advanced Solid Tumors  VNP20009 in Treating Patients With Advanced Solid Tumors
VNP20009 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Vion Pharmaceuticals ,
Synopsis: RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose or minimum effective dose and associated toxic effects of VNP20009 in patients with advanced solid tumors. II. Determine whether VNP20009 can be detected in tumors after treatment in these patients. III. Determine the pharmacokinetics of this treatment regimen in these patients. IV. Determine the antitumor effects of this treatment regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive VNP20009 IV over 4 hours on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable disease or partial or complete response (CR) may receive additional courses every 35 days for up to 12 total doses or 2 courses past a CR. Cohorts of 3-6 patients receive escalating doses of VNP20009 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. An additional 6-9 patients are treated at the MTD. PROJECTED ACCRUAL: A total of 14-45 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 advanced and/or metastatic solid tumors refractory to standard curative or palliative therapy and for which no other conventional therapy exists - Measurable or evaluable metastatic disease - No brain metastases unless previously treated and no evidence of recurrence - No lymphoma or other hematologic malignancy --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy and recovered - Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - Endocrine therapy: At least 2 weeks since prior hormonal therapy and recovered; No concurrent steroids that could depress the immune system unless indicated for severe reactions - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered - Surgery: At least 2 weeks since prior surgery and recovered; No prior splenectomy; No concurrent palliative surgery - Other: Recovered from any other prior anticancer therapies; No concurrent antibiotics; No concurrent immunosuppressives or any other medications that could suppress the immune system; No other concurrent treatment for malignancy; No requirement for immediate palliative treatment --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 3 months - Hematopoietic: Granulocyte count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hematocrit at least 30% (transfusion allowed); No known bleeding disorder - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present); Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver metastases present); PT and PTT no greater than 1.5 times ULN; Hepatitis B surface antigen negative; No chronic active hepatitis B; No end-stage liver disease - Renal: Creatinine no greater than 2.0 mg/dL; No urinary tract stones; No end-stage renal disease - Cardiovascular: No known valvular disease; No known clinically significant atherosclerotic disease, peripheral vascular disease, or arterial aneurysm; No unstable angina; No artificial heart valves - Pulmonary: No severe oxygen-dependent chronic obstructive pulmonary disease - Other: No artificial implant that cannot be removed (e.g., prosthetic hips or knees or other devices); No permanent central venous catheters; No gallstones; No active infection; No documented Salmonella infection; No tumor fever or fever of unknown origin or cause; Daily maximum temperature no greater than 38.0 degrees Celsius; HIV negative; No documented immunodeficiency; No other life-threatening illness; No history of allergic reaction or hypersensitivity to quinolone or cephalosporin antibiotics; No commercial food handlers, day-care workers, or health-care workers; No patients unable to avoid close personal contact with severely immunosuppressed individuals (e.g., other patients on myelosuppressive cancer chemotherapy); Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: CDR0000068187; CCF-IRB-3663,NCI-V00-1622,VION-CLI-008
Study Start Date: May 2000
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006254
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections
2. KRN5500 in Treating Patients With Metastatic Solid Tumors
3. CHS 828 in Treating Patients With Solid Tumors
4. Chemotherapy in Treating Patients With Advanced Solid Tumors
5. ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy
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VNP20009 in Treating Patients With Advanced Solid Tumors
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