CompletedPhase 2

Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

United States11 participantsStarted 2000-09

Plain-language summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic head and neck cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Biopsy-proven recurrent squamous cell carcinoma of the head and neck
. Stage 4 disease, either at initial presentation or at recurrence. Patients with metastatic disease at initial presentation must have received at least one prior course of cytotoxic chemotherapy.
. Patients who present with metastatic disease should have received no more than one prior regimen of chemotherapy or biologic therapy to be eligible. Patients who initially received adjuvant or induction chemotherapy and then recurred may have received one additional cycle of chemotherapy or biologic therapy at the time of recurrence. Patients may have received any number of cycles of a particular regimen of chemotherapy.
. Patients must have a life expectancy of at least 3 months
. Biopsy of the recurrent lesion(s) is encouraged but not mandatory for enrollment.
. Performance status grade 0-2.
. Serum creatinine \<= 1.5 mg/dL.
. Serum transaminases and bilirubin \<= 1.5 time normal.

Exclusion criteria

. Pregnant women (women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrollment in the study); women who are currently breast-feeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine the response rate, time to progression, median survival, and percent one-year survival

Timeframe: one-year survival

Trial details

NCT IDNCT00006471

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-07

View on ClinicalTrials.gov More Head and Neck Cancer trials