Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Metastatic/Recurrent Colorectal Carcinomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040599
• Other study ID #: IM-T-hMN14-02
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2000
• Est. completion date: January 2004

Study information

• Verified date: January 2008
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Colon Cancer
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms
• Colorectal Tumor
• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• hMN14 (labetuzumab)

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	University Hospital Dresden	Dresden
Hungary	University of Szeged Medical Center	Szeged
Sweden	Uppsala University Hospital	Uppsala
Switzerland	Centre Pluridisciplinaire d'Oncologie	Lausanne
United States	Hoag Cancer Center	Newport Beach	California
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Bay Pines VA Medical Center	Saint Petersburg	Florida
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Sweden,  Switzerland,