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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00263783
First received: December 8, 2005
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.


Condition Intervention Phase
Cancer
Drug: MEDI-522
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose. [ Time Frame: Study Day 1 up to 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Will be assessed using the variables of area under the concentration curve (AUC) which will be calculated by the trapezoidal rule, peak concentration (Cmax), time to peak concentration (Tmax), half life [ Time Frame: 35 days after the first dose ] [ Designated as safety issue: Yes ]
  • Measured pharmacokinetic parameters may be one of the factors used in determination of the Phase II regimen. [ Time Frame: Appx. 5 days after the 4th weekly dose ] [ Designated as safety issue: Yes ]
  • Antitumor Activity: The antitumor activity of MEDI-522 in patients with refractory solid tumors will be assessed by calculating tumor response rate and time to disease progression. [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2001
Study Completion Date: June 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-522
Drug: MEDI-522
MEDI-522 will be administered at doses of 1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg. [As a 30 minute IV infusion initially as a single dose (single-dose treatment period) and 2 to 5 weeks later as weekly doses (multiple-dose treatment period) for up to 1 year.]

  Eligibility

Ages Eligible for Study:   18 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263783

Locations
France
Institut Gustave Roussy
Villejuf, France, 94805
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Luz Hammershaimb, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: Luz Hammershaimb, M.D., V.P., Clinical Dev., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00263783     History of Changes
Other Study ID Numbers: MI-CP065
Study First Received: December 8, 2005
Last Updated: January 28, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014