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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

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.

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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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hMN14 (labetuzumab)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No