Tipifarnib for Cancer

Recruiting in Palo Alto (17 mi)

+180 other locations

Overseen byChristine A Pratilas

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests tipifarnib, a drug that may help stop cancer growth, on children with certain advanced cancers that have a specific genetic change. The drug works by targeting and blocking the growth of these cancer cells.

Research Team

Christine A Pratilas

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for children and young adults up to 21 years old with advanced solid tumors, lymphoma, or histiocytic disorders that have a change in the HRAS gene. They should be able to swallow tablets, have recovered from previous cancer treatments, and meet certain health criteria like blood counts. Pregnant individuals or those on certain medications are excluded.

Inclusion Criteria

I have recovered from side effects of previous cancer treatments.

I am between 12 and 21 years old.

I have received stem cell infusions and/or radiation therapy within the specified timeframes.

See 13 more

Exclusion Criteria

You are currently taking other medications for cancer.

I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

I have an infection that is not responding to treatment.

See 8 more

Treatment Details

Interventions

Tipifarnib (Farnesyltransferase Inhibitor)

Trial OverviewThe effectiveness of Tipifarnib is being tested on patients whose cancers have returned or spread and have an HRAS gene alteration. This drug aims to block cancer cell growth linked to this genetic change and potentially shrink tumors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (tipifarnib)Experimental Treatment7 Interventions

Patients receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo tumor disease evaluation with PET scan, CT scan, MRI, or MIBG scintigraphy throughout the trial. Patients may undergo bone marrow aspiration or biopsy at baseline, or if there is suspicion of bone marrow metastasis, or when a complete or partial response is identified, or if there is disease progression in the marrow suspected. Patients may undergo blood specimen collections throughout the trial.