Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

NCT00006046 | Terminated Phase 1 Results FDA Drug

• 3 other identifiers: CDR0000068062MSKCC-00005LUD1999-007
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Dose-limiting Toxicities (DLTs)

  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.

  up to 10 weeks.

Secondary Outcomes (1)

• Number of Patients With Tumor Responses

  8 weeks

Study Arms (5)

Hu3S193 10 mg/m2

EXPERIMENTAL

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

Hu3S193 25 mg/m2

EXPERIMENTAL

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

Hu3S193 50 mg/m2

EXPERIMENTAL

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

Hu3S193 100 mg/m2

EXPERIMENTAL

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

Hu3S193 200 mg/m2

EXPERIMENTAL

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

Interventions

monoclonal antibody hu3S193 BIOLOGICAL

Hu3S193 10 mg/m2; Hu3S193 100 mg/m2; Hu3S193 200 mg/m2; Hu3S193 25 mg/m2; Hu3S193 50 mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Hu3S193 monoclonal antibody

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• Sydney Welt, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: May 21, 2003
• Study Start: July 12, 2000
• Primary Completion: October 5, 2001
• Study Completion: September 24, 2002
• Last Updated: October 4, 2023
• Results First Posted: August 9, 2021

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)