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A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma Clinical research trials and A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma. A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma clinical trial. Participants frequently obtain the most expert healthcare available for their A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma  A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma
A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma
For Condition: Ovarian Neoplasms
Status: No longer recruiting
Sponsor(s): United Therapeutics ,
Synopsis: The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment with the cell culture product will be evaluated.
Details: This is a prospective, open-label, randomized, parallel group, Phase 1/2 study in female patients with Stage III/IV epithelial ovarian cancer. The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. The study will also evaluate the safety of the cell culture product and the immune responses in patients following treatment. The study is being conducted in three phases: 1. The pharmacokinetic assessment phase will include at least 24 patients, who will be randomized into two treatment groups to receive a single 2 mg dose of either ascites fluid product or cell culture product. 2. The treatment phase will continue administration of two more monthly doses (weeks 4 and 8) and all patients will receive cell culture product. Study patients will be followed for safety and immune response through week 20. 3. The continuation phase will continue administration of cell culture product at the discretion of the investigator on a quarterly schedule for up to 104 weeks in eligible patients who tolerate therapy. Patients who continue treatment will be followed for serious adverse events and all patients will be followed for survival for up to 2 years after first treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin. - FIGO Stage III or IV prior to study. - Serum CA125 level >35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level > or = 100 U/mL following surgery or immunohistochemical evidence of tumor tissue expressing CA125. - Completed primary treatment following initial diagnosis, including chemotherapy involving a cisplatin or carboplatin-based regimen. - Functional Performance Status < or = 2 by ECOG scale. - Medical assessment consistent with prognosis for an expected survival of at least 3 months. - Voluntary participation, signed informed consent and willingness to complete all study procedures. Exclusion Criteria: - No surgery (not including minor surgical procedures), chemotherapy, or radiotherapy (whole abdomen, abdominopelvic or pelvic) within 4 weeks prior to first dose of study drug. - No known refractory or recurrent disease requiring chemotherapy during the 4 weeks prior to, or planned 10 weeks after first study dose. - Serum CA125 levels not >800 U/mL at baseline evaluation. - No gross (clinically evident) ascites. - No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 4 weeks of first study dose. - No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes or serum human anti-murine antibodies (HAMA) not above upper limit of normal at baseline evaluation. - Not on long-term chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids. - Ovarian tumors must be of low malignant potential or with noninvasive disease. - No concurrent malignancy (except non-melanoma of the skin or in situ carcinoma of cervix), unless curative treatment was received and patient has been disease-free for > or = 5 years. - No known allergy to murine proteins, or prior documented anaphylactic reaction to any drug, or known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure. - No previous splenectomy. - No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn's Disease, MS, ankylosing spondylitis). - No recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; no acquired, hereditary, or congenital immunodeficiencies. - No uncontrolled diseases or illness other than this cancer. - No significant cardiovascular abnormalities including uncontrolled hypertension, uncontrolled angina, uncontrolled arrhythmias, or CHF (NYHA Classes II-IV). - No compromised hematopoietic function defined as a hemoglobin <10.0 g/dL or lymphocyte count <300 mm3 or neutrophil count <1000 mm3 or platelet count <100,000 mm3. - No hepatic dysfunction defined as a bilirubin above upper limit of normal, LDH, SGOT and SGPT >2 times upper limits of normal, or albumin <3.5 g/dL. - No renal dysfunction defined as serum creatinine above upper limit of normal. - No pregnancy or breast-feeding (While pregnancy is unlikely in view of the disease and previous surgery, patients who the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method.) - No other investigational drugs within 30 days of enrollment. - No contraindications present to the use of pressor agents. - No HIV infection, or recent history of drug abuse, alcoholism, or hepatitis.
Total Enrollment: 24
Location and Contact Information:
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Women's Cancer Research Foundation
Miami, Florida, 33143
United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
United States
Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32804
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
St. Joseph's Medical Center
South Bend, Indiana, 46634
United States
Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920
United States
Additional Information:
Study ID Numbers: OVA-Gy-16;
Study Start Date: March 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034138
Other Ovarian Neoplasms Studies:
1. Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer
2. Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer
3. Study of T900607-sodium in previously treated patients with ovarian cancer.
4. Phase 1-2a Study of TLK286 in Combination with Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
5. Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma
Related Studies:
Other Ovarian Neoplasms Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma
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