Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

NCT ID: NCT00040599

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2004-01-31

Brief Summary

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

Conditions

Colorectal Cancer; Colon Cancer; Rectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

hMN14 (labetuzumab)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Principal Investigators

William Wegener, MD

Role: STUDY_CHAIR

Gilead Sciences

Locations

Hoag Cancer Center

Newport Beach, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Bay Pines VA Medical Center

St. Petersburg, Florida, United States

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Zentralklinik Bad Berka

Bad Berka, , Germany

University Hospital Dresden

Dresden, , Germany

University of Szeged Medical Center

Szeged, , Hungary

Uppsala University Hospital

Uppsala, , Sweden

Centre Pluridisciplinaire d'Oncologie

Lausanne, , Switzerland

Countries

United States; Germany; Hungary; Sweden; Switzerland

Other Identifiers

IM-T-hMN14-02

Identifier Type: -

Identifier Source: org_study_id