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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-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.

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 1
Date Submitted to PDQ		2002-10-24
Information Last Verified		2007-01-06

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00052663