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

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