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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

Phase 1
18 Years
Not Enrolling
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



- 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

- 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.

Inclusion Criteria


- Histologically confirmed (by the NIH pathology department) diagnosis of 1 of the

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of 4-HPR/LXS oral powder

Safety Issue:


Principal Investigator

Shivaani Kummar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Medical Oncology Branch


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

March 2011

Related Keywords:

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Lymphoma
  • Neoplasms



USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Childrens Hospital Los AngelesLos Angeles, California  90027
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182