Lonafarnib + Temozolomide for Glioblastoma

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of lonafarnib when given together with temozolomide and to see how well they work in treating patients with glioblastoma multiforme that is has come back or did not respond to previous treatment with temozolomide. Lonafarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lonafarnib together with temozolomide may kill more tumor cells.

Research Team

Vinay Puduvalli, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I've had a scan within the required time after surgery, without increasing my steroid dose.

I have recovered from side effects of my last cancer treatment as per the specified time frames.

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

Treatment Details

Interventions

• Lonafarnib (Farnesyltransferase Inhibitor)
• Temozolomide (Alkylating Agent)

Trial Overview 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.

Participant Groups

Group I: Treatment (temozolomide and lonafarnib) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+