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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fenretinide

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