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

NCT00734682 | Completed Phase 1 DMC

• 1 other identifier: 08103
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified). Patients who are wild type or heterozygous for the UGT1A1\*28 gene will received Nanoliposomal CPT-11. The total anticipated accrual will be approximately 36 patients (depending upon the actual MTD). The investigators hypothesis is that this new formulation of CPT-11 will increase survival over that seen in historical controls who have recurrent gliomas because CPT-11 will be encapsulated in a liposome nanoparticle, which has been seen to reduce toxicities from the drug.

Conditions

Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma

Keywords

Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Mixed Oligoastrocytoma; Malignant Astrocytoma NOS; Nanoliposomal CPT-11; liposomal irinotecan

Outcome Measures

Primary Outcomes (1)

• To assess the safety and pharmacokinetics of NL CPT-11 in patients with recurrent malignant glioma stratified based on UGT1A1 genotyping.

  1-2 years

Secondary Outcomes (1)

• To determine the maximum tolerated dose of NL CPT-11 in these patient populations.

  1-2 years

Study Arms (1)

Nanoliposomal CPT-11

EXPERIMENTAL

All patients are treated with nanoliposomal CPT-11

Drug: Nanoliposomal CPT-11

Interventions

Nanoliposomal CPT-11 DRUG

Depending on UGT1A1 genotyping status, patients are either given a starting dose of 120 mg/m\^2 (wild type) or 60 mg/m\^2 IV q3 weeks.

Also known as: NL CPT-11, liposomal irinotecan

Nanoliposomal CPT-11

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Astrocytoma; Oligodendroglioma

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Michael Prados, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2014-12

Locations

US (1)