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Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas

Phase 1
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas


- To assess if full doses of enzastaurin hydrochloride and temozolomide can be used in
combination for the treatment of patients with primary gliomas.

- To determine the recommended phase II dose.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride once or twice daily on days 1-28* and oral
temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

NOTE: *During the first course only, patients also receive enzastaurin hydrochloride on day

Patients undergo blood sample collection on day 22 of course 1 and on day 5 of course 2 for
pharmacokinetic studies of enzastaurin hydrochloride.

After completion of study treatment, patients are followed within 30 days and then every 3
months thereafter.

Inclusion Criteria


- Histologically confirmed primary supratentorial glioma

- WHO histologic grade 3 or 4

- Patients who have undergone prior treatment for low-grade glioma that has
transformed to glioblastoma (biopsy proven) allowed

- Amenable to standard temozolomide treatment

- First or second recurrent disease after prior surgery and/or radiotherapy OR newly
diagnosed disease that is not amenable to radiotherapy (e.g., multifocal disease)


- ECOG or WHO performance status 0-2

- Hemoglobin ≥ 10.0 g/dL

- Neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.5 x upper limit of normal (ULN)

- Alkaline phosphatase and transaminases ≤ 2.5 x ULN

- Serum creatinine < 1.7 mg/dL

- Not pregnant or lactating

- Negative pregnancy test

- Fertile patients must use effective contraception

- Clinically normal cardiac function

- No ischemic heart disease within the past 6 months

- No clinically significant abnormalities or uncontrolled cardiac arrhythmia by ECG

- QTc interval ≤ 450 msec (males) or ≤ 470 msec (females) by baseline 12-lead ECG

- No history of congenital long QTc syndrome

- No history of stroke

- No other prior or concurrent malignancy within the past 5 years except cone biopsied
carcinoma of the cervix or adequately treated basal or squamous cell skin carcinoma

- No unstable systemic diseases

- No active uncontrolled infections

- No uncontrolled hypertension

- No psychological, familial, sociological, or geographical condition that would
preclude study participation

- Must be able to swallow tablets


- See Disease Characteristics

- No more than 1 prior chemotherapy regimen in the adjuvant setting or for first

- Prior temozolomide allowed provided there was no disease progression during
temozolomide treatment or within 6 weeks of completing temozolomide treatment

- Prior surgery for primary brain tumor within the past 3 months allowed

- Patients who are receiving corticosteroid treatment must be on a stable or decreasing
dose for at least 1 week before study entry

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- At least 14 days since prior and no concurrent enzyme-inducing antiepileptic drugs
including, but not limited to, any of the following:

- Phenytoin

- Carbamazepine

- Phenobarbital

- More than 30 days since prior and no other concurrent investigational treatments

- No concurrent anticoagulant treatment (e.g., warfarin)

- Low molecular weight heparin for patients who require anticoagulant therapy
after starting study treatment may be allowed

- No concurrent routine use of colony-stimulating factors

- No other concurrent anticancer agents

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase II dose

Safety Issue:


Principal Investigator

Roy Rampling, MD, PhD

Investigator Affiliation:

University of Glasgow


United States: Federal Government

Study ID:




Start Date:

July 2007

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult mixed glioma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult glioblastoma
  • adult anaplastic ependymoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pineal gland astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms