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Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

Primary Purpose

Colorectal Cancer, Colon Cancer, Rectal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
hMN14 (labetuzumab)
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hoag Cancer Center
  • Washington Hospital Center
  • Bay Pines VA Medical Center
  • University of Pittsburgh Cancer Institute
  • Virginia Mason Medical Center
  • Zentralklinik Bad Berka
  • University Hospital Dresden
  • University of Szeged Medical Center
  • Uppsala University Hospital
  • Centre Pluridisciplinaire d'Oncologie

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 1, 2002
Last Updated
August 12, 2021
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00040599
Brief Title
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumor
Keywords
Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
hMN14 (labetuzumab)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wegener, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Hoag Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Bay Pines VA Medical Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101-2799
Country
United States
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
D99437
Country
Germany
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
University of Szeged Medical Center
City
Szeged
Country
Hungary
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
S-75185
Country
Sweden
Facility Name
Centre Pluridisciplinaire d'Oncologie
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

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Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

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