Clinical trial NCT00041691: Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Neoplasms
Keywords: Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumor
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2002-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Gilead Sciences
name: Lauri Welles, MD
role: STUDY_CHAIR
affiliation: Gilead Sciences
name: Terence Rugg, MD
role: STUDY_DIRECTOR
References: