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Home > "S" Clinical Trials Conditions > Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer  Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
For Condition: Breast Cancer,Breast Neoplasms,Colorectal Neoplasms,Colon Cancer,Rectal Cancer,Colorectal Carcinoma,Colorectal Cancer
Status: No longer recruiting
Sponsor(s): Immunomedics, Inc. ,
Synopsis: The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast 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: - Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma - Measurable lesion diagnosed by CT scan - Recurrent/metastatic disease considered surgically unresectable. Prior/Concurrent Therapy: - Chemotherapy: Patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (Enrollment must occur at least 4 weeks beyond last treatment) - Other: Prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study Patient Characteristics/Inclusion Criteria: - Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months. - Hematopoietic: WBC >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, CEA < 300 ng/mL - Hepatic: Serum bilirubin /= 40% by required MUGA/2D-ECHO study. - Pulmonary: Patients with FEV1 >/= 60% by required Pulmonary Function Tests - Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
TerenceRugg, Study Director, Immunomedics, Inc.
Hoag Cancer Center
Newport Beach, California, 92658
United States
Additional Information:
Study ID Numbers: IM-T-hMN14-04;
Study Start Date: February 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041652
Other Colorectal Neoplasms Studies:
1. Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
2. Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma
3. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
4. Phase I Dose-finding Study of E7070 in Combination with Irinotecan
Related Studies:
Other Colorectal Neoplasms Clinical Trials
Other California Clinical Trials
Other Newport Beach Clinical Trials
Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
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