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

October 30, 2018 updated by: M.D. Anderson Cancer Center

A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rate, time to progression, median survival, and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide.
  • Determine the pharmacokinetics and safety of this drug in these patients.

OUTLINE: Patients receive oral fenretinide every 12 hours on days 1-7. Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response continue treatment for 1 year.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Biopsy-proven recurrent squamous cell carcinoma of the head and neck
  2. 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.
  3. 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.
  4. Patients must have a life expectancy of at least 3 months
  5. Biopsy of the recurrent lesion(s) is encouraged but not mandatory for enrollment.
  6. Performance status grade 0-2.
  7. Serum creatinine <= 1.5 mg/dL.
  8. Serum transaminases and bilirubin <= 1.5 time normal.
  9. Age >= 18 years.
  10. White blood cell count >= 3,000; platelets >= 100,000; hemoglobin >= 9mg/dl.
  11. Signed informed consent.
  12. Women of childbearing potential must agree to utilize two methods of effective birth control, one barrier, one hormonal, or should abstain from sexual intercourse that could result in pregnancy. Contraceptive measures should be continued for at least one month after fenretinide administration has been discontinued.
  13. It is recommended that male patients with female partners of childbearing potential use barrier contraception while on fenretinide.

Exclusion Criteria:

  1. 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.
  2. Grade 2 or greater peripheral neuropathy
  3. Concurrent treatment with cytotoxic chemotherapy or radiation
  4. Serious infection or other intercurrent illness requiring immediate therapy.
  5. Inability to take oral medications, or other medical or social factors interfering with compliance.
  6. Patients on high dose synthetic or natural Vitamin A derivatives (>= 10,000 per day).
  7. Patients should not take any anti-oxidants such as Vitamin C or E.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fenretinide
Drug: Fenretinide
1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.
Other Names:
  • 4-HPR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the response rate, time to progression, median survival, and percent one-year survival
Time Frame: one-year survival
To determine the response rate, time to progression, median survival, and percent one-year survival.
one-year survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Bonnie S. Glisson, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

November 6, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID99-334
  • P30CA016672 (U.S. NIH Grant/Contract)
  • U01CA070172 (U.S. NIH Grant/Contract)
  • MDA-ID-99334 (Other Identifier: UT MD Anderson Cancer Center)
  • NCI-610
  • CDR0000068294 (Registry Identifier: NCI PDQ)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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