Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer 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 Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer Clinical research trials and Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer 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 Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer 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 Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer 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.

Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer



Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

For Condition: stage 3 ovarian epithelial cancer,recurrent ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiolabeledmonoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Giving radiolabeled monoclonal antibody directly into the abdominal cavity may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody therapy directly into the abdominal cavity in treating patients who have advanced ovarian epithelial cancer.
Details: OBJECTIVES: Primary - Determine the safety and maximum tolerated dose of intraperitoneal yttrium Y 90 monoclonal antibody Hu3S193 (Y90 MOAB Hu3S193) in patients with advanced ovarian epithelial cancer. Secondary - Determine the localization and whole body and abdominal clearance of this drug in these patients using indium In 111 monoclonal antibody Hu3S193 and gamma camera imaging. - Determine the serum pharmacokinetics of Y90 MOAB Hu3S193 in these patients using gamma well counting. - Determine the antibody response in patients treated with this drug. OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Hu3S193 (Y90 MOAB Hu3S193). Patients receive intraperitoneal (IP) technetium Tc 99m sulfur colloid and undergo abdominal imaging on day 1. Provided distribution of technetium Tc 99m sulfur colloid is deemed adequate, patients then receive IP Y90 MOAB Hu3S193 and IP indium In 111 monoclonal antibody Hu3S193 (for imaging) over 30 minutes on day 1. Within 3-5 hours after antibody administration, patients undergo whole body imaging and single-photon emission-computed tomography (SPECT) imaging of the abdomen and pelvis. Cohorts of 3-6 patients receive escalating doses of Y90 MOAB Hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for at least 2 years and then every 6 months for up to 5 years. PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-mucinous ovarian adenocarcinoma - Persistent or recurrent intraperitoneal disease after platinum/taxane-based therapy for stage III ovarian cancer - Residual disease less than 2 cm - No active parenchymal disease (stage IV) - No symptomatic extraabdominal metastases - No known CNS tumor involvement PATIENT CHARACTERISTICS: Age - Any age Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding disorders Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - LVEF at least 50% - No New York Heart Association class III or IV heart disease - No clinically significant arrhythmia by ECG - No evidence of prior myocardial infarction Pulmonary - FEV_1 at least 60% of predicted - FVC at least 60% of predicted - Diffusion capacity at least 55% of predicted Other - Not pregnant or nursing - Negative pregnancy test - No other serious illness that would preclude study participation - No serious infection requiring antibiotics - No chronic inflammatory bowel disease - Human antimouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy - No prior murine monoclonal antibody therapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No immunosuppressive therapy for 30 days after the administration of yttrium Y 90 monoclonal antibody Hu3S193
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ChaitanyaDivgi,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Chaitanya  Divgi 212-639-2459


Additional Information:
Study ID Numbers:  CDR0000339682;  MSKCC-03069,LUDWIG-LUD01-018
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072410

Other Recurrent Ovarian Epithelial Cancer Studies:
1. UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

2. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Persistent or Platinum Refractory Stage III or IV Ovarian Cancer

3. Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy

4. Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy

5. Capecitabine in Treating Women With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Related Studies:

Other recurrent ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials

Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
Modify your Search

  Other recurrent ovarian epithelial cancer Clinical Trials
  Other New York Clinical Trials
  Other New York City Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103