|
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Safety Study of 90Y-hMN14 to Treat Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Clinical research trials and Safety Study of 90Y-hMN14 to Treat Colorectal Cancer medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Safety Study of 90Y-hMN14 to Treat Colorectal Cancer. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety Study of 90Y-hMN14 to Treat Colorectal Cancer clinical trial. Participants frequently get the best healthcare available for their Safety Study of 90Y-hMN14 to Treat Colorectal Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Safety Study of 90Y-hMN14 to Treat Colorectal Cancer  Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
For Condition: Colorectal Cancer,Rectal Cancer,Colon Cancer,Colorectal Neoplasms,Colorectal Carcinoma,Colorectal Tumor
Status: Completed
Sponsor(s): Immunomedics, Inc. ,
Synopsis: The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of colorectal cancer.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Disease Characteristics: - Patients with a documented histologic or cytologic diagnosis of a colonic or rectal malignancy. - Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. - Patients with at least one identified (confirmed) and measurable tumor site* with no tumor site > 5 cm in the greatest dimension. Prior/Concurrent Therapy: - Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry. - Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. Patients must have completed chemotherapeutic agents four weeks prior to study entry. - Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA). - Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cGy for the liver, and 2,000 cGy for the lungs and kidneys). Patients who have had standard pelvic field radiation as adjuvant therapy for rectal carcinoma will be eligible only after the MTD is established. - Other: Any experimental therapy (i.e., drugs, biologicals, procedures) for the primary malignancy, either during or within four weeks prior to study entry. Patient Characteristics/Inclusion Criteria: - Age Range: Male or Female at least 18 years of age - Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months. - Hematopoietic: Hemoglobin > 10 g/dL; WBC > 3000 per mm3; Granulocyte count > 1,500 per mm3; Platelet count > 100,000 per mm3 - Hepatic: Total bilirubin < 1.5 times the institutional upper limit of normal (IULN)AST or ALT < 2 x IULN - Renal: Creatinine < IULN - Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO study. - Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests. - Other: Patients who have had a prior imaging study with a murine monoclonal antibody may be included. Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.
Total Enrollment: 72
Location and Contact Information:
Overall Study Official:
WilliamWegener, Study Chair, Immunomedics, Inc.
Virginia Mason Medical Center
Seattle, Washington, 98101-2799
United States
Bay Pines VA Medical Center
St. Petersburg, Florida, 33744
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Centre Pluridisciplinaire d’Oncologie
Lausanne, , CH-1011
Switzerland
University of Szeged Medical Center
Szeged, ,
Hungary
Zentralklinik Bad Berka
Bad Berka, , D99437
Germany
University Hospital Dresden
Dresden, , D-01307
Germany
Hoag Cancer Center
Newport Beach, California, 92658
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Uppsala University Hospital
Uppsala, , S-75185
Sweden
Additional Information:
Study ID Numbers: IM-T-hMN14-02;
Study Start Date: January 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040599
Other Colorectal Neoplasms Studies:
1. Phase I Dose-finding Study of E7070 in Combination with Irinotecan
2. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
3. Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
4. Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma
Related Studies:
Other Colorectal Neoplasms Clinical Trials
Other Clinical Trials
Other Lausanne Clinical Trials
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
|
|
|
|
|
|
|
|
