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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00041691
Enrollment
30
Registered
2002-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumor

Brief 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.

Interventions

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026