Status:
COMPLETED
Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors
Lead Sponsor:
MedImmune LLC
Conditions:
Cancer
Eligibility:
All Genders
18-18 years
Phase:
PHASE1
Brief Summary
To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.
Eligibility Criteria
Inclusion
- Male or post menopausal female patients with histologically confirmed advanced refractory solid tumors for which no reasonable therapy exists. Patient is not required to have measurable disease.
- Age \>18 years
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see APPENDIX 1 for details).
- Patients who had prior surgery, radiation, or chemotherapy will be eligible provided at least 4 weeks have elapsed prior to study initiation. Patients must have recovered from treatment-related toxicities, and surgical wounds must be healed.
- Patients who have had prior immunotherapy with approved agents are eligible.
- Patients must have hemoglobin \>10.0 g/dL, ANC \>1,000/mm3, WBC \>3,000/mm3,000/mm3, platelets ³100,000/mm3, bilirubin £2.0 mg/dL, AST/ALT no greater than 5 times the upper limit of normal (ULN), and serum creatinine \<1.5 mg/dL (or calculated creatinine clearance ³60 mL/min).
- Patients must have prothrombin time (PT) and partial thromboplatin time (PTT) less than upper limit of normal or international normalized ratio (INR) less than 1.1.
- Patients must have thyroxine (T4) and thyroid-stimulating hormone (TSH) within normal limits.
- Patients must be informed of and understand the investigational nature of this trial and give written informed consent prior to receipt of any study medication or beginning study procedures.
Exclusion
- Patient has known brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis.
- Patient has respiratory insufficiency requiring oxygen treatment, or has lymphangitic involvement of lungs.
- Patient has evidence of hematemesis, melena, hematochezia, or hematuria (2 or greater on urine dipstick).
- Patient has a history of a significant adverse event related to previously administered humanized monoclonal antibody.
- Patient has known HIV or hepatitis virus infection.
- Patient has prior myocardial infarction or angina, or uncontrolled hypertension (systolic BP \>140 mm Hg).
- Patient has either prior strokes or transient ischemic attacks.
- Patient has active infections requiring systemic antiinfective therapy or other physical or psychological illnesses that would preclude drug administration or patient compliance.
- Patient has donated blood or received an investigational agent in the last 4 weeks.
- Patient has a history of active illness or behavior, including substance dependence or abuse that, in the opinion of the investigator, might pose additional risk in administering the study drug to the patient.
- General medical or psychological conditions that would not permit the patient to complete the study or sign the informed consent
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2002
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00263783
Start Date
March 1 2001
End Date
June 1 2002
Last Update
January 29 2009
Active Locations (1)
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1
Institut Gustave Roussy
Villejuf, France, 94805