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

Gilead Sciences

Status and phase

Terminated

Phase 1

Conditions

Colorectal Neoplasms

Treatments

Drug: hMN14 (labetuzumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00041691

IM-T-hMN14-06

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.