|
Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer Clinical research trials and Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer. Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer  Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer
Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer
For Condition: recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Garden State Cancer Center
Synopsis: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by therapy used to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus peripheral stem cell transplantation in treating patients who have refractory or recurrent ovarian epithelial cancer.
Details: OBJECTIVES: I. Determine the normal organ and tumor dosimetry with yttrium Y 90 monoclonal antibody MN-14 using indium In 111 monoclonal antibody MN-14 as pretherapy in patients with advanced ovarian epithelial cancer. II. Evaluate the extent and duration of antitumor response in these patients on this regimen. PROTOCOL OUTLINE: This is a dose escalation study of yttrium Y 90 monoclonal antibody MN-14 (90Y hMN-14). Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days -17 to -13, followed by leukapheresis on days -14 to -12. If an adequate number of CD34+ cells are not harvested, bone marrow is also collected. Patients receive pretherapy targeting consisting of indium In 111 monoclonal antibody MN-14 over 30 minutes on day -7. At least 1 confirmed tumor site must be targeted. Patients receive 90Y hMN-14 IV over 30-45 minutes on day 0. PBSC is reinfused within 7 to 14 days after 90 hMN-14 administration. Patients receive G-CSF SQ or IV until blood counts recover. Cohorts of 3-6 patients receive escalating doses of 90Y hMN-14 until the maximum tolerated dose (MTD) is determined. The MTD is defined as either the dose at which no more than 1 of 6 patients experiences dose limiting toxicity or the threshold radiation doses to lungs, kidney, and liver are reached. Patients are followed weekly for 1 month, every 2 weeks for 2 months, monthly for 3 months, every 3 months for 2 years, and then every 6 months for 5 years. PROJECTED ACCRUAL: Approximately 48-51 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically refractory or recurrent ovarian epithelial cancer; Resistant to platinum or taxane containing chemotherapy within past 6 months - Autologous peripheral blood stem cells (PBSC) or bone marrow available - At least 1 measurable site confirmed by CT targeted pretherapy indium; In 111 monoclonal antibody MN-14 imaging - No bone marrow involvement --Prior/Concurrent Therapy-- - Biologic therapy: No prior imaging studies with murine monoclonal antibodies showing reactivity with yttrium Y 90 monoclonal antibody MN-14 (90Y hMN-14) - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy to index lesion and recovered; No prior radiotherapy to greater than 25% of red marrow; No prior radiotherapy to maximum tolerated levels for any critical organ (e.g., lung, liver, or kidney) - Surgery: At least 4 weeks since prior major surgery - Other: No concurrent antiretroviral medication --Patient Characteristics-- - Age: 18 to 80 - Performance status: Karnofsky 70-100%; ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT less than 2.0 times upper limit of normal (ULN) - Renal: Creatinine less than 1.5 times ULN; Creatinine clearance at least 50 mL/min - Cardiovascular: LVEF at least 50% by MUGA - Pulmonary: FVC, FEV1, and DLCO at least 70% of predicted - Other: Not pregnant Fertile patients must use effective contraception during and for 3 months after study; No AIDS-related illness; No concurrent significant medical complications that would preclude compliance; No severe anorexia, nausea, or vomiting; No history of allergy or antibodies to 90Y hMN-14
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackBurton, Study Chair, Garden State Cancer Center
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Garden State Cancer Center
Belleville, New Jersey, 07103
United States
Additional Information:
Study ID Numbers: CDR0000067299; CMMI-C-039A-98,NCI-H99-0044,NCI-V99-1570
Study Start Date: August 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004177
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
2. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
3. Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
4. Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer
5. Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other New Jersey Clinical Trials
Other Belleville Clinical Trials
Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer
|
|
|
|
|
|
|
|
