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A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently
with radiotherapy and temozolomide followed by temozolomide alone in patients with
glioblastoma multiforme.

- Determine the safety and dose-limiting toxicities of this regimen in these patients.

Secondary

- Determine the progression-free survival (PFS) and overall survival (OS) of patients
treated with this regimen.

- Compare the observed median values of PFS and OS obtained in this study to the
historical median values of 6.9 months and 14.6 months, respectively.

OUTLINE: This is a dose-escalation study of nelfinavir mesylate.

Patients receive oral nelfinavir mesylate twice daily beginning 7-10 days before the
initiation of chemoradiotherapy and continuing until the completion of chemoradiotherapy.
Patients undergo radiotherapy once daily 5 days a week and receive concurrent oral
temozolomide once daily for 6 weeks. Beginning 4 weeks after completion of nelfinavir
mesylate and chemoradiotherapy, patients receive oral temozolomide alone once daily on days
1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed WHO grade IV supratentorial astrocytoma (glioblastoma
multiforme)

- Newly diagnosed disease

- Has undergone maximal surgical resection

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine < 1.5 times upper limit of normal (ULN)

- AST or ALT < 2 times ULN

- Serum bilirubin < 1.5 mg/dL

- No known HIV infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior cranial radiotherapy

- More than 30 days since prior investigational agents

- No other concurrent investigational agents

- No concurrent use of any of the following drugs:

- Antiarrhythmics (i.e., amiodarone or quinidine)

- Antimycobacterials (i.e., rifampin)

- Ergot derivatives (i.e., dihydroergotamine, ergonovine, ergotamine, or
methylergonovine)

- Herbal products (i.e., St. John's wort)

- HMG-CoA reductase inhibitors (i.e., lovastatin or simvastatin)

- Neuroleptics (i.e., pimozide)

- Sedatives and/or hypnotics (i.e., midazolam or triazolam)

- Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥
14 days prior to study entry

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of nelfinavir mesylate

Safety Issue:

Yes

Principal Investigator

Jay F. Dorsey, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

Unspecified

Study ID:

CDR0000644278

NCT ID:

NCT00915694

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283