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Safety Study of 90Y-hMN14 to Treat Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

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

NCT00040599•Gilead Sciences

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Disease Characteristics:
•Patients with a documented histologic or cytologic diagnosis of a colonic or rectal malignancy.
•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.

Exclusion 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.
•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.

Locations (10)

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

Key Dates

Start Date

January 1, 2000

Completion Date

January 1, 2004

Last Updated

August 19, 2021

Enrollment

Estimated participants

Conditions

Colorectal CancerColon CancerRectal CancerColorectal NeoplasmsColorectal CarcinomaColorectal Tumor

Interventions

hMN14 (labetuzumab)

DRUG

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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