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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: monoclonal antibody hu3S193 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma
Actual Study Start Date : July 12, 2000
Actual Primary Completion Date : October 5, 2001
Actual Study Completion Date : September 24, 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 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.
 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.
 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.
 Biological: monoclonal antibody hu3S193


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006046


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Investigators
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Study Chair: Sydney Welt, MD Memorial Sloan Kettering Cancer Center
More Information
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Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00006046    
Other Study ID Numbers: CDR0000068062
MSKCC-00005 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
LUD1999-007 ( Other Identifier: Ludwig Institute for Cancer Research )
First Posted: May 21, 2003    Key Record Dates
Results First Posted: August 9, 2021
Last Update Posted: August 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ludwig Institute for Cancer Research:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs