Clinical trial NCT00040599: Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
Official title: A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Metastatic/Recurrent Colorectal Carcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumor
Keywords: Colon Cancer
Rectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumor
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2002-07-03
Enrollment: 72
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 colorectal cancer.


Eligibility criteria: Disease Characteristics:

* Patients with a documented histologic or cytologic diagnosis of a colonic or rectal malignancy.
* Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
* Patients with at least one identified (confirmed) and measurable tumor site\* with no tumor site \> 5 cm in the greatest dimension.

Prior/Concurrent Therapy:

* Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry.
* Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. Patients must have completed chemotherapeutic agents four weeks prior to study entry.
* Biologic Therapy: Patients who have received a 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 radiotherapy within four weeks of study entry. 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 organ (e.g., 3,000 cGy for the liver, and 2,000 cGy for the lungs and kidneys). Patients who have had standard pelvic field radiation as adjuvant therapy for rectal carcinoma will be eligible only after the MTD is established.
* Other: Any experimental therapy (i.e., drugs, biologicals, procedures) for the primary malignancy, either during or within four weeks prior to study entry.

Patient Characteristics/Inclusion Criteria:

* Age Range: Male or Female at least 18 years of age
* Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
* Hematopoietic: Hemoglobin \> 10 g/dL; WBC \> 3000 per mm3; Granulocyte count \> 1,500 per mm3; Platelet count \> 100,000 per mm3
* Hepatic: Total bilirubin \< 1.5 times the institutional upper limit of normal (IULN)AST or ALT \< 2 x IULN
* Renal: Creatinine \< IULN
* Cardiovascular: Patients with LVEF \>/= 50% by required MUGA/2D-ECHO study.
* Pulmonary: Patients with DFCO and FEV1 \>/= 60% by required Pulmonary Function Tests.
* Other: Patients who have had a prior imaging study with a murine monoclonal antibody may be included. 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 performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Cancer Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Saint Petersburg
country: United States
facility: Bay Pines VA Medical Center
state: Florida
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Szeged
country: Hungary
facility: University of Szeged Medical Center
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Lausanne
country: Switzerland
facility: Centre Pluridisciplinaire d'Oncologie
Study officials:
affiliation: Gilead Sciences
name: William Wegener, MD
role: STUDY_CHAIR
References: