Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
NCT00023933CI-TRIAL-00009153completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iodine I 131 monoclonal antibody CC49-deltaCH2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (monoclonal antibody)
- description
- Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8. Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the MTD is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.
- interventionNames
- Drug: iodine I 131 monoclonal antibody CC49-deltaCH2
Primary outcomes (1)
- measure
- Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- Immune response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the colon or rectum * Not amenable to surgical resection * Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan * TAG-72 positive * Performance status - ECOG 0-2 * WBC greater than 3,500/mm\^3 * Platelet count greater than 125,000/mm\^3 * Hemoglobin greater than 10 g/dL * No nucleated RBC or significant teardrop RBC morphology * Bilirubin less than 1.5 mg/dL * SGOT/SGPT less than 4 times normal * Hepatitis B surface antigen negative * Creatinine less than 2.0 mg/dL * HIV negative * No other malignancy within the past 5 years except basal cell skin cancer * No allergy to iodine * No detectable antibody to monoclonal antibody CC49 * Not pregnant or nursing * Fertile patients must use effective contraception * At least 3 weeks since prior immunotherapy and recovered * No prior bone marrow or stem cell transplantation * No other concurrent immunotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered * No concurrent chemotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of red marrow * No concurrent radiotherapy * See Disease Characteristics * At least 3 weeks since prior surgery and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.