Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma
NCT00006046CI-TRIAL-00070169terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor recruitment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monoclonal antibody hu3S193 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Hu3S193 10 mg/m2
- description
- 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.
- interventionNames
- Biological: monoclonal antibody hu3S193
- type
- EXPERIMENTAL
- label
- Hu3S193 25 mg/m2
- description
- 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.
- interventionNames
- Biological: monoclonal antibody hu3S193
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.