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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00041691
• Other study ID #: IM-T-hMN14-06
• Status: Terminated
• Phase: Phase 1

Study information

• Verified date: January 2003
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• hMN14 (labetuzumab)

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States,