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GPX-100 in Treating Patients With 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 GPX-100 in Treating Patients With Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. GPX-100 in Treating Patients With Solid Tumors Clinical research trials and GPX-100 in Treating Patients With 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 GPX-100 in Treating Patients With Solid Tumors. GPX-100 in Treating Patients With 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 GPX-100 in Treating Patients With Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their GPX-100 in Treating Patients With 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 > "G" Clinical Trials Conditions > GPX-100 in Treating Patients With Solid Tumors  GPX-100 in Treating Patients With Solid Tumors
GPX-100 in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): Gem 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 GPX-100 in treating patients who have solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of GPX-100 in outpatients with incurable, solid tumors who are not candidates for effective systemic therapy. II. Evaluate and quantify the toxicity of GPX-100 in this patient population. III. Identify any changes in disease status in this patient population. PROTOCOL OUTLINE: This is an open label, multicenter, dose escalation study. Patients receive GPX-100 IV once every 3 weeks. Patients receive 2 courses of treatment in the absence of disease progression or dose limiting toxicity. Treatment may continue for up to 6 courses (4 courses with prior doxorubicin) in patients with responding or non-progressing disease. One patient is entered at each of the first 3 dose levels. Cohorts of 3-6 patients are entered at subsequent dose levels. The maximum tolerated dose of GPX-100 is defined as the dose at which no more than 2 instances of dose limiting toxicity are observed in 6 patients. PROJECTED ACCRUAL: A maximum of 30 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-- - Incurable, solid tumors in patients who are not candidates for effective systemic therapy; Progressive disease defined as a 25% increase in diameter of measurable lesions or appearance of new lesions --Prior/Concurrent Therapy-- - Biologic therapy: Prior biologic therapy allowed; No concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered; No greater than 300 mg/m2 cumulative dose of doxorubicin; No concurrent chemotherapy - Endocrine therapy: At least 4 weeks since prior hormone therapy; No concurrent anticancer hormone therapy; Concurrent corticosteroids allowed - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: Not specified - Other: At least 4 weeks since prior investigational drug therapy; No other concurrent investigational therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 - Life expectancy: Greater than 16 weeks - Hematopoietic: WBC at least 4000/mm3; Platelet count at least 125,000/mm3; Hemoglobin at least 8 g/dL - Hepatic: Bilirubin within normal limits; SGOT no greater than 1.5 times normal (2.5 times normal with disease involvement); Alkaline phosphatase no greater than 2.5 times normal; PT or PTT less than 1.5 times normal - Renal: Creatinine no greater than 1.5 times normal; Creatinine clearance at least 60 mL/min - Cardiovascular: No history of congestive heart failure, active ischemic heart disease, or uncontrolled hypertension; No myocardial infarction within the past 6 months - Other: Not pregnant or nursing (negative pregnancy test required); Fertile patients must use effective contraception; No weight loss of 10% or more in the past 3 months; No frequent vomiting; No severe anorexia
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrederickDechow, Study Chair, Gem Pharmaceuticals
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Additional Information:
Study ID Numbers: CDR0000066409; GEM-97-002,NCI-V98-1441,MAYO-IRB-153-98
Study Start Date: August 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003403
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
2. Endostatin in Treating Patients With Advanced Solid Tumors
3. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
4. Benzoylphenylurea in Treating Patients With Advanced Cancer
5. UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Florida Clinical Trials
Other Jacksonville Clinical Trials
GPX-100 in Treating Patients With Solid Tumors
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