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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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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

Conditions
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Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: fenretinide lipid matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fenretinide lipid matrix|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of 4-HPR/LXS oral powder |  |  | 
| Safety |  |  | 
| Toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of fenretinide in normal peripheral blood mononuclear cells |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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