Fenretinide Lym-X-Sorb™ in Treating Patients With Recurrent or Resistant Solid Tumors or Lymphoma

March 7, 2012 updated by: National Institutes of Health Clinical Center (CC)

Phase I Trial of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder (4-HPR/LXS Oral Powder) (4-HPR) in Adults With Solid Tumors and Lymphomas

RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorb™ , work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide Lym-X-Sorb™ in treating patients with recurrent or resistant solid tumors or lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) in patients with recurrent and/or resistant solid tumors or lymphomas.
  • To define the toxicities of 4-HPR/LXS oral powder in these patients.
  • To determine the plasma pharmacokinetics of 4-HPR/LXS oral powder in these patients.

Secondary

  • To determine the level of fenretinide delivered as 4-HPR/LXS oral powder in normal peripheral blood mononuclear cells.

OUTLINE: This is a multicenter study.

Patients receive oral fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) (mixed in food carriers) three times daily on days 1-7. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease response or better may receive additional courses of treatment at the discretion of the treating physician and principal investigator.

Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

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
    • California
      • Los Angeles, California, United States, 90027-0700
        • Childrens Hospital Los Angeles
      • Los Angeles, California, United States, 90089
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed (by the NIH pathology department) diagnosis of 1 of the following:

    • Solid tumor malignancy that is metastatic or unresectable
    • Lymphoma for which standard treatment or curative measures do not exist, or are associated with minimal patient survival benefit
  • Recurrent and/or resistant disease
  • Measurable or evaluable disease

  • No known brain metastases

    • Patients whose brain metastatic disease status has remained stable for ≥ 3 months after treatment may be eligible at the discretion of the principal investigator (without steroids or anti-seizure medications)

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelets ≥ 100,000/µL (CTCAE v.3 grade 1 thrombocytopenia allowed if explained by involvement of the bone marrow by lymphoma)
  • Total bilirubin ≤ 1.5 times normal institutional limits (2.5 mg/dL for patients with Gilbert's syndrome)
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test

  • Fertile patients must use two methods of birth control, including at least one highly effective method (e.g., intrauterine device [IUD], hormonal birth control pills/injections/implants, tubal ligation or partner's vasectomy), and one additional effective method (e.g., latex condoms, diaphragm, or cervical cap), prior to, during, and for 2 months after completion of study treatment

    • Men must use a latex condom every time they have sexual intercourse during therapy and for 2 months after discontinuing fenretinide, even if they have had a successful vasectomy

  • No clinically significant illnesses which could compromise participation in the study, including, but not limited to, any of the following:

    • Active or uncontrolled infection
    • Immune deficiencies or confirmed diagnosis of HIV infection
    • Uncontrolled diabetes
    • Uncontrolled hypertension
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Myocardial infarction within the past 6 months
    • Uncontrolled cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • No known wheat gluten allergy or allergy or sensitivity to the study drug
  • No history of pancreatitis as evidenced by elevated amylase or lipase ≥ grade 2 and accompanied by symptoms of pancreatitis (e.g., abdominal pain)

PRIOR CONCURRENT THERAPY:

  • Recovered from adverse events and/or toxicity due to prior chemotherapy or biologic therapy
  • No chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas, mitomycin C, or UCN-01)
  • At least 1 month since any prior radiotherapy or major surgery
  • At least 2 weeks since any prior administration of study drug in an exploratory IND/phase 0 study
  • Patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy
  • No concurrent sulfonamides
  • No other concurrent investigational agents
  • No other concurrent cancer chemotherapy, or immunomodulating agents (including systemic corticosteroids)

  • Patients must not take any drugs suspected of causing pseudo tumor cerebri, including any of the following:

    • Tetracycline
    • Nalidixic acid
    • Nitrofurantoin
    • Phenytoin
    • Sulfonamides
    • Lithium
    • Amiodarone
    • Vitamin A (except as part of routine total parenteral nutrition vitamin supplements or in a single daily standard dose oral multivitamin supplement)
  • No concurrent herbal supplements or other alternative therapy medications

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Safety
Maximum tolerated dose of 4-HPR/LXS oral powder

Secondary Outcome Measures

Outcome Measure
Level of fenretinide in normal peripheral blood mononuclear cells

Collaborators and Investigators

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

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Shivaani Kummar, MD, NCI - Medical Oncology Branch

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.

General Publications

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

August 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 25, 2007

First Posted (Estimate)

January 9, 2008

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080030
  • 08-C-0030
  • NCI-P07187
  • CDR0000580777

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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