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Clinical Trials (PDQ®)

  • First Published: 11/24/2002
  • Last Modified: 5/14/2010

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Clinical Trials (PDQ®)

Phase II Study of LY317615 in Patients With Recurrent High-Grade Gliomas

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

LY317615 in Treating Patients With Recurrent Gliomas

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted18 and overNCINCI-03-C-0018
NCT00052663

Objectives

  1. Determine the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.
  2. Determine the toxic effects of this drug in these patients.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed intracranial malignant glioma, including 1 of the following:
    • Glioblastoma multiforme
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Malignant astrocytoma (not otherwise specified)

  • Unequivocal evidence of tumor progression by MRI or CT scan
    • Must be on a steroid dose that has been stable for at least 5 days

  • Failed prior radiotherapy

Prior/Concurrent Therapy:

Biologic therapy

  • At least 1 week since prior interferon or thalidomide
  • No concurrent anticancer immunotherapy

Chemotherapy

  • Recovered from prior chemotherapy
  • At least 2 weeks since prior vincristine
  • At least 6 weeks since prior nitrosoureas
  • At least 3 weeks since prior procarbazine
  • No concurrent standard anticancer chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 1 week since prior tamoxifen
  • Concurrent steroids allowed for the control of signs and symptoms of increased intracranial pressure

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy

Surgery

  • Recovered from prior surgery
  • Prior recent resection of recurrent or progressive tumor allowed
    • Residual disease allowed

Other

  • Recovered from prior therapy
  • Prior radiosensitizer allowed
  • At least 4 weeks since other prior cytotoxic therapy
  • At least 2 weeks since prior investigational agents
  • At least 2 weeks since prior enzyme-inducing antiepileptic drugs
  • At least 1 week since prior isotretinoin
  • At least 1 week since other prior noncytotoxic agents
  • No other concurrent investigational agents

Patient Characteristics:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 8 weeks

Hematopoietic

  • WBC at least 3,000/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic

  • SGOT less than 2 times upper limit of normal (ULN)
  • Bilirubin less than 2 times ULN
  • No significant active hepatic disease

Renal

  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No significant active renal disease

Cardiovascular

  • No significant active cardiac disease

Other

  • No significant active psychiatric disease
  • No active infection requiring IV antibiotics
  • No other significant medical illness that cannot be adequately controlled with appropriate therapy or that would preclude study entry
  • No disease that would obscure toxicity or dangerously alter drug metabolism
  • No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3-6 months after study participation

Expected Enrollment

A maximum of 150 patients will be accrued for this study within 1 year.

Outline

Patients are stratified according to tumor type (anaplastic astrocytoma vs glioblastoma multiforme) and concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs) (no vs yes).

Patients receive oral LY317615 once daily for 6 weeks. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses beyond the 9 courses of therapy at the investigator's discretion.

Patients are followed within 2 weeks after the completion of therapy.

Published Results

Kreisl TN, Kotliarova S, Butman JA, et al.: A phase I/II trial of enzastaurin in patients with recurrent high-grade gliomas. Neuro Oncol 12 (2): 181-9, 2010.[PUBMED Abstract]

Fine HA, Kim L, Royce C, et al.: Results from phase II trial of enzastaurin (LY317615) in patients with recurrent high grade gliomas. [Abstract] J Clin Oncol 23 (Suppl 16): A-1504, 115s, 2005.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Howard Fine, MD, Principal investigator
Ph: 301-402-6298

Registry Information
Official Title A Phase II Trial Of LY317615 In Patients With Recurrent High-Grade Gliomas
Trial Start Date 2002-10-01
Trial Completion Date 2008-06-13
Registered in ClinicalTrials.gov NCT00052663
Date Submitted to PDQ 2002-10-24
Information Last Verified 2007-01-06

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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