rhEndostatin Protein Involving Pediatric Patients With Cancer

Stopped early · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to determine the effect of rhEndostatin on the formation of new blood vessel factors, and to perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells (cells in the body that help the tumor build more blood vessels).

Key facts

Study ID

NCT00165373

Run by

Dana-Farber Cancer Institute

People needed

21

Starts

2003-01-01

Expected to finish

2005-01-01

Last updated by the study team

2007-12-28

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have had a histological verification of solid tumor at the original diagnosis. For patients with brain stem gliomas and optic pathway tumors, the requirement for histological evaluation may be waived. The patient's disease must be considered refractory to conventional/standard therapy, or a disease for which no conventional therapy exists and is progressive. Patients must have measurable disease for this study.
• Agree to having a central venous access placed
• Be between 2 and 18, inclusive, years of age
• Aspartate aminotransferase and alanine aminotransferase less than 2.5 x ULN-
• Total bilirubin less than 2.0 x ULN
• Serum creatinine less than 2.0 mg/dL or a creatinine clearance or glomerular filtration rate less than 2 times normal for age
• Absolute neutrophil count greater than or equal to 1,000/mm3
• Platelets greater than or equal to 100,000/mm3 (transfusion independent)
• Hemoglobin greater than 8.0 g/dL
• Have an estimated life expectancy of at least 3 months
• Have a Karnofsky performance status greater than 50 for patients aged 10 years or older and a Lansky performance status greater than 50 for patients aged 2 to less than 10 years
• Patients are required to have had an EKG, echocardiogram, and pulse oximetry within age-appropriate levels prior to starting therapy.
• If a woman or man of child producing potential, agree to use effective contraceptive methods (A negative pregnancy test within 72 hours before the administration of rhEndostatin protein will be required for women of childbearing potential.)

You may not qualify if…

• Patients with leukemia
• Be pregnant or nursing
• Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
• Have any condition that is likely to interfere with regular follow-up
• Have participated in any clinical trial involving conventional or investigational drugs or devices within 4 weeks prior to rhEndostatin protein administration
• Have received radiotherapy or chemotherapy within 4 weeks prior to rhEndostatin protein administration
• Have received nitrosourea or mitomycin C less than 6 weeks prior to initiation of therapy
• Be receiving concurrent treatment with therapeutic doses of heparin or enoxaparin sodium (Lovenox®) (rhEndostatin protein has a heparin binding domain.)
• Have had major surgery within 2 weeks of starting rhEndostatin protein administration This does not include placement of a vascular access device.
• Have a history of bone marrow transplantation or extensive radiotherapy (craniospinal, total body, or radiotherapy to more than half of the pelvis) within the previous 4 months
• Have ionized calcium levels below the lower limits of normal
• Have a history of myocardial infarction within the last 6 months, angina pectoris/angina equivalent in the last 6 months (the patient may be on antianginal medications if the symptoms can be entirely controlled), or have uncontrolled congestive heart failure
• Have an active infection
• Have additional uncontrolled serious medical or psychiatric illness

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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