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Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery

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ClinicalTrials.gov Identifier: NCT00041691
Recruitment Status : Terminated
First Posted : July 15, 2002
Last Update Posted : June 24, 2005
Information provided by:
Immunomedics, Inc.

Brief Summary:
The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: hMN14 (labetuzumab) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Disease Characteristics:

  • Patients with documented histologic and cytologic diagnosis of colon or rectal malignancy
  • Patients with documented status post surgical resection of primary cancer or metastases
  • Limited residual disease (i.e., CEA serum levels < 15 ng/mL and negative baseline CT scans, or no lesion > 1 cm)

Prior/Concurrent Therapy:

  • Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy, other investigational therapy for cancer, or surgical procedures at least six weeks prior to study entry.
  • Patients must have recuperated from surgery and toxicities (as a result of previous therapy) sufficiently prior to study entry
  • Biologic Therapy: Patients who have received a murine, 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 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 organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys)

Patient Characteristics/Inclusion Criteria:

  • Performance Status: Patients with Karnofsky performance status > 70%
  • Hematopoietic: ANC >/= 1.5 x 10/L; Hemoglobin >/= 10 g/dL; Platelets >/= 100 x 10/L
  • Renal: Serum Creatinine </= 1.5 x ULN
  • Hepatic: Serum Bilirubin </= 1.5 ULN; AST and ALT </= 2.5 x ULN; Alk Phosphatase </= 2.5 x ULN
  • Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO tests
  • Pulmonary: Patients with DF and FEV1 >/= 60% by required Pulmonary Function Tests
  • Central Nervous System: Patients with known metastatic disease to the CNS are excluded.
  • Other: 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 preformed on each premenopausal female of childbearing potential immediately prior to entry into study. Patients must understand and give written informed consent.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041691

United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Immunomedics, Inc.
Study Chair: Lauri Welles, MD Immunomedics, Inc.
Study Director: Terence Rugg, MD Immunomedics, Inc.

ClinicalTrials.gov Identifier: NCT00041691     History of Changes
Other Study ID Numbers: IM-T-hMN14-06
First Posted: July 15, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2003

Keywords provided by Immunomedics, Inc.:
Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumor

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases