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

Inclusion Criteria

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