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Farnesyltransferase Inhibitor

Lonafarnib + Temozolomide for Glioblastoma

Phase 1

Waitlist Available

Led By John de Groot

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically proven supratentorial glioblastoma multiforme (GBM) or gliosarcoma

Patients must have shown unequivocal evidence for tumor recurrence or progression by magnetic resonance imaging (MRI) scan after radiation therapy; the scan done prior to study entry documenting progression will be reviewed by the treating physician to document tumor volume changes to provide a gross assessment of growth rate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 11 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of lonafarnib when given with temozolomide to see if it can help treat patients with glioblastoma multiforme.

Who is the study for?

This trial is for patients with a specific brain cancer called glioblastoma multiforme or gliosarcoma that has returned or didn't respond to temozolomide. Participants must have had prior treatment with temozolomide, can have up to two previous chemotherapy regimens, and need a stable health status (Karnofsky performance >60). They should not have used farnesyl transferase inhibitors before.

What is being tested?

The trial tests the combination of lonafarnib and temozolomide on recurrent or resistant glioblastoma multiforme. It aims to find the safest dose of lonafarnib when combined with temozolomide and assess how effectively this duo can kill tumor cells by blocking cell growth enzymes and stopping cell division.

What are the potential side effects?

Potential side effects include those typical of chemotherapy such as fatigue, nausea, vomiting, decreased blood cell counts leading to increased infection risk, hair loss, mouth sores, and neurological issues like headaches or seizures due to brain tumor location.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of brain tumor.

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My MRI shows my tumor has grown after radiation therapy.

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My recent scans show my tumor is growing, and my steroid use hasn’t increased.

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I had surgery over 2 weeks ago, am recovering well, and can do most daily activities.

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I am mostly able to care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 11 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 11 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 11 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Progression free survival (PFS)

Treatment-related toxicities

Side effects data

From 2009 Phase 2 trial • 29 Patients • NCT00425607

11%

Stroke

Vomiting

Bacterial infection

Subdural hematoma

Extremity-lower (gait/walking)

Neuropathy: Sensory

Hypokalemia

100%

80%

60%

40%

20%

Study treatment Arm

Lonafarnib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (temozolomide and lonafarnib)Experimental Treatment2 Interventions

Patients receive temozolomide PO QD on days 1-7 and 15-21 and lonafarnib PO BID on days 8-14 and 22-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Lonafarnib

2003

Completed Phase 3

~720