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Trial record 7 of 7 for:    hu3s193

Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006046
Recruitment Status : Terminated (poor recruitment)
First Posted : May 21, 2003
Results First Posted : August 9, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Tracking Information
First Submitted Date  ICMJE July 5, 2000
First Posted Date  ICMJE May 21, 2003
Results First Submitted Date  ICMJE July 15, 2021
Results First Posted Date  ICMJE August 9, 2021
Last Update Posted Date August 9, 2021
Actual Study Start Date  ICMJE July 12, 2000
Actual Primary Completion Date October 5, 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2021)
Number of Patients With Dose-limiting Toxicities (DLTs) [ Time Frame: up to 10 weeks. ]
Toxicity was graded in accordance with the Common Toxicity Scale developed by NCI (1998) where Grade 1 represents the lowest toxicity grade and Grade 5 death. Dose-limiting toxicity (DLT) was defined as Grade 3 and Grade 4 adverse events which were at least possibly related to study treatment.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2021)
Number of Patients With Tumor Responses [ Time Frame: 8 weeks ]
Complete response (CR); disappearance of all measurable disease lasting a minimum of 4 weeks. Partial Response (PR); 50% or greater decrease in the sum of the products of the perpendicular diameters or all measurable lesions, without development of new lesions or increase in size of any lesion, lasting a minimum of 4 weeks. Progressive disease (PD); Appearance of new lesions or increase by 25% or more in size of any measurable lesion. Stable disease (SD); Not meeting criteria for response or progression.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Official Title  ICMJE Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma
Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer.

Detailed Description

OBJECTIVES:

  • Determine the toxicity, maximum tolerated dose, and pharmacokinetics of monoclonal antibody hu3S193 in patients with advanced colorectal carcinoma.
  • Determine the immune response in these patients treated with this regimen.

OUTLINE: This is a dose escalation study.

Patients receive monoclonal antibody hu3S193 (mAb hu3S193) IV over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest. Patients with stable or responding disease at week 10 receive maintenance mAb hu3S193 weekly. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of mAb hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Biological: monoclonal antibody hu3S193
Study Arms  ICMJE
  • Experimental: Hu3S193 10 mg/m2
    Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
    Intervention: Biological: monoclonal antibody hu3S193
  • Experimental: Hu3S193 25 mg/m2
    Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
    Intervention: Biological: monoclonal antibody hu3S193
  • Experimental: Hu3S193 50 mg/m2
    Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
    Intervention: Biological: monoclonal antibody hu3S193
  • Experimental: Hu3S193 100 mg/m2
    Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
    Intervention: Biological: monoclonal antibody hu3S193
  • Experimental: Hu3S193 200 mg/m2
    Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
    Intervention: Biological: monoclonal antibody hu3S193
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 15, 2021)
7
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 24, 2002
Actual Primary Completion Date October 5, 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven stage IV colorectal carcinoma.
  • Failed or refused conventional chemotherapy.
  • Lewis Y antigen present on more than 50% of tumor cells.
  • Measurable or evaluable disease.
  • No central nervous system (CNS) tumor involvement.
  • Karnofsky 80-100%.
  • Life expectancy: At least 6 weeks.
  • Granulocyte count greater than 1,500/mm^3.
  • Platelet count greater than 100,000/mm^3.
  • Bilirubin no greater than 1.0 mg/dL.
  • Prothrombin time less than 3 times upper limit of normal.
  • Creatinine no greater than 1.4 mg/dL.
  • Female patients of childbearing age and male patients must be asked to use effective contraception during the study.
  • At least 4 weeks since other prior immunotherapy. Exclusion Criteria
  • New York Heart Association class III or IV heart disease.
  • Serious infection requiring antibiotics or other serious illness.
  • Pregnancy or nursing.
  • History of bleeding gastric ulcers or pancreatitis.
  • Diabetes mellitus requiring insulin.
  • Human antimouse antibodies (HAMA).
  • No prior mouse monoclonal antibody or antibody fragments.
  • Illness requiring the use of steroids or other anti-inflammatory agents.
  • Positive anti-hu3S193 antibody (HAHA) titer.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006046
Other Study ID Numbers  ICMJE CDR0000068062
MSKCC-00005 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
LUD1999-007 ( Other Identifier: Ludwig Institute for Cancer Research )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ludwig Institute for Cancer Research
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Ludwig Institute for Cancer Research
Original Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sydney Welt, MD Memorial Sloan Kettering Cancer Center
PRS Account Ludwig Institute for Cancer Research
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP