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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00589381
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : March 8, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Drug: fenretinide lipid matrix Phase 1

Detailed Description:



  • 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.


  • 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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Primary Outcome Measures :
  1. Maximum tolerated dose of 4-HPR/LXS oral powder
  2. Safety
  3. Toxicity

Secondary Outcome Measures :
  1. Level of fenretinide in normal peripheral blood mononuclear cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00589381

United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: Shivaani Kummar, MD NCI - Medical Oncology Branch

Publications of Results: Identifier: NCT00589381     History of Changes
Other Study ID Numbers: 080030
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
unspecified adult solid tumor, protocol specific
recurrent adult Hodgkin lymphoma
recurrent adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
recurrent adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
Waldenström macroglobulinemia
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
recurrent small lymphocytic lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases