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A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies Clinical research trials and A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies. A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies clinical trial. Test subjects typically receive the most effective healthcare possible for their A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 > "A" Clinical Trials Conditions > A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies  A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies
A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies
For Condition: Metastases, Neoplasm,Neoplasms
Status: Recruiting
Sponsor(s): American Bioscience ,
Synopsis: This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic agent that may be more readily tolerated than some standard therapies. Patients will be given the new chemotherapeutic medicine once a week, by intravenous route, for three weeks, followed by a rest week. Treatment will be repeated in four week cycles if the patient improves on the therapy, and if there are no adverse events that require withdrawal of medication.
Details: This will be a dose-escalating study. ABI-007 will be administered as an outpatient infusion for three weeks followed by a week of rest. The treatment course will repeat every 28 days. No pretreatment will normally be considered necessary. Patients will have white blood cell and platelet counts monitored as will indications of performance (Karnofsky Performance Status), and will be asked to describe adverse events, if present. Patients will be treated for a minimum of two cycles to be evaluable for the study, and may continue in the study for four cycles within the study, if tumor response and safety parameters warrant continuing. Patients may continue on study medication beyond this at the investigator's discretion.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - At least 18 years of age - Life expectancy of at least 2 months - Off all therapy for at least 3 weeks prior to study drug administration - Biopsy-proven diagnosis of advanced malignancy - Patients with solid tumors who have failed standard therapy - Karnofsky Performance Status of 70% or 0-2 SWOG Perfomance Status - Hemoglobin at least 9 - White Blood Cell count of at least 3000/mm3 with absolute neutrophil count of at least 1500/mm3 - Platelet count of at least 100,000/mm3 - Serum Creatinine less than 2 mg/dL - Transaminases less than 3X the upper limit of normal - Patient must provide informed consent - Serum Bilirubin less than 1.5 mg/dL
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
MichaelHawkins, Study Director, American Bioscience, Inc.
American Bioscience, Inc. *Recruiting*
Raleigh, North Carolina,
United States
Recruiting Connie Cosentino 919-789-9141
Additional Information:
Study ID Numbers: CA-005-0;
Study Start Date: April 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046423
Other Metastases, Neoplasm Studies:
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2. Endolymphatic Sac Tumors in a Population of Patients with von Hippel-Lindau Disease:The Natural History and Pathobiology, and a Prospective Non-Randomized Clinical Trial of Hearing Preservation Surgery in Patients with Early Stage Endolymphatic Sac Tumors
3. Collection of Blood, Bone Marrow, Tumor or Tissue Samples
4. Dose Determination of 5-Fluorouracil in Combination with Leucovorin and the Experimental Drug UCN-01 to Treat Cancer
5. Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion for 10 Days
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A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies
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