Clinical Trial Details
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NCT00734682 : A Phase I Trial of Nanoliposomal CPT-11 (NL CPT-11) in Patients With Recurrent High-Grade Gliomas
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Patients with histologically proven intracranial malignant glioma are eligible .
-All patients must sign an informed consent

- Patients must be > 18 years old, and with a life expectancy > 8 weeks.

- Patients must have a Karnofsky performance status of > 60.

- Patients must have recovered from the toxic effects of prior therapy

- Patients must have adequate bone marrow function (WBC > 3,000/µl, ANC > 1,500/mm3,
platelet count of > 100,000/mm3, and hemoglobin > 10 gm/dl), adequate liver function
(SGOT and bilirubin < 2 times ULN), and adequate renal function (creatinine < 1.5
mg/dL and/or creatinine clearance > 60 cc/min) Patients must have shown
radiographic evidence for tumor progression by MRI or CT scan. A scan should be
performed within 14 days prior to registration and on a steroid dose that has been
stable for at least 5 days. -Patients having undergone recent resection of recurrent
or progressive tumor will be eligible as long as all of the following conditions

- They have recovered from the effects of surgery.

- Residual disease following resection of recurrent malignant glioma is not
mandated for eligibility into the study.

- Patients must have failed prior radiation therapy

- Patients with prior therapy that included interstitial brachytherapy or stereotactic
radiosurgery must have confirmation of true progressive disease

- Women of childbearing potential must have a negative ß-HCG pregnancy test documented
within 14 days prior to registration.

- Patients may have had treatment for any number of prior relapses.

Exclusion Criteria:

- Patients must not have any significant medical illnesses that in the investigator
opinion cannot be adequately controlled

- Patients with a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission and off of all therapy
for that disease for a minimum of 3 years are ineligible.

- Patients must not have active infection or serious intercurrent medical illness.

- Patients must not be pregnant/breast feeding and must agree to practice adequate

- Patients must not have any disease that will obscure toxicity or dangerously alter
drug metabolism.

- Patients must not have received prior therapy with irinotecan.

- Patients with 7/7 (homozygous) UGT1A1*28 genotyping will be excluded from the study.

- Patients receiving enzyme-inducing anticonvulsants or other enzyme inducing drugs are
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