Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery
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
1 other identifier
interventional
30
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2002
CompletedFirst Posted
Study publicly available on registry
July 15, 2002
CompletedAugust 19, 2021
January 1, 2003
July 12, 2002
August 12, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (2)
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lauri Welles, MD
Gilead Sciences
- STUDY DIRECTOR
Terence Rugg, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2002
First Posted
July 15, 2002
Last Updated
August 19, 2021
Record last verified: 2003-01