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

Sponsor:	Immunomedics, Inc.
Information provided by:	Immunomedics, Inc.
ClinicalTrials.gov Identifier:	NCT00041691

Purpose

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	Intervention	Phase
Colorectal Neoplasms	Drug: hMN14 (labetuzumab)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

Drug Information available for: Labetuzumab

U.S. FDA Resources

Further study details as provided by Immunomedics, Inc.:

Estimated Enrollment:

30

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041691

Locations

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.

Investigators

Study Chair:	Lauri Welles, MD	Immunomedics, Inc.
Study Director:	Terence Rugg, MD	Immunomedics, Inc.

More Information

No publications provided

Study ID Numbers:	IM-T-hMN14-06
Study First Received:	July 12, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00041691 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:

Colorectal Cancer
Colon Cancer
Rectal Cancer

Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumor

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009