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Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors

Phase 1
18 Years
18 Years
Not Enrolling

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Trial Information

Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors

Inclusion Criteria:

- 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

- 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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose.

Outcome Time Frame:

Study Day 1 up to 8 weeks

Safety Issue:


Principal Investigator

Luz Hammershaimb, MD

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC


United States: Food and Drug Administration

Study ID:




Start Date:

March 2001

Completion Date:

June 2002

Related Keywords:

  • Cancer