Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery

Study Overview
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Brief Summary
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The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.

Official Title
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A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: hMN14 (labetuzumab)


Participation Criteria
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Eligibility Criteria
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Disease Characteristics: Patients with documented histologic and cytologic diagnosis of colon or rectal malignancy Patients with documented status post surgical resection of primary cancer or metastases Limited residual disease (i.e., CEA serum levels < 15 ng/mL and negative baseline CT scans, or no lesion > 1 cm) Prior/Concurrent Therapy: Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy, other investigational therapy for cancer, or surgical procedures at least six weeks prior to study entry. Patients must have recuperated from surgery and toxicities (as a result of previous therapy) sufficiently prior to study entry Biologic Therapy: Patients who have received a murine, chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA) Radiotherapy: No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys) Patient Characteristics/Inclusion Criteria: Performance Status: Patients with Karnofsky performance status > 70% Hematopoietic: ANC >/= 1.5 x 10/L; Hemoglobin >/= 10 g/dL; Platelets >/= 100 x 10/L Renal: Serum Creatinine </= 1.5 x ULN Hepatic: Serum Bilirubin </= 1.5 ULN; AST and ALT </= 2.5 x ULN; Alk Phosphatase </= 2.5 x ULN Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO tests Pulmonary: Patients with DF and FEV1 >/= 60% by required Pulmonary Function Tests Central Nervous System: Patients with known metastatic disease to the CNS are excluded. Other: Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into study. Patients must understand and give written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hMN14 (labetuzumab)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumor