Status:
COMPLETED
A Phase I Trial of Nanoliposomal CPT-11 (NL CPT-11) in Patients With Recurrent High-Grade Gliomas
Lead Sponsor:
University of California, San Francisco
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I study of Nanoliposomal CPT-11 in patients with Recurrent high-grade gliomas. Patients must have a histologically proven intracranial malignant glioma, which includes glioblastoma mul...
Detailed Description
Patients with recurrent malignant glioma will receive Nanoliposomal CPT-11 at the time of relapse. The dose will be adjusted according to a phase-1 dose escalation scheme. Patients will receive drug i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00734682
Start Date
August 1 2008
End Date
December 1 2014
Last Update
January 7 2015
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143