A Phase I Trial of Nanoliposomal CPT-11 (NL CPT-11) in Patients With Recurrent High-Grade Gliomas

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 apply:

  * 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 contraception.
* 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 excluded.