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

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

MedlinePlus related topics:

Cancer Colorectal Cancer

ChemIDplus related topics:

Labetuzumab

U.S. FDA Resources

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

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

Study ID Numbers:	IM-T-hMN14-06
First Received:	July 12, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00041691
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

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Gastrointestinal Neoplasms

Intestinal Diseases

Rectal cancer

Rectal Diseases

Intestinal Neoplasms

Colorectal Neoplasms

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

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