Clinical trial · Interventional
Fenretinide Lym-X-Sorb™ in Treating Patients With Recurrent or Resistant Solid Tumors or Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fenretinide lipid matrix | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Maximum tolerated dose of 4-HPR/LXS oral powder
- measure
- Safety
- measure
- Toxicity
Secondary outcomes (1)
- measure
- Level of fenretinide in normal peripheral blood mononuclear cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKummar S, Gutierrez ME, Maurer BJ, Reynolds CP, Kang M, Singh H, Crandon S, Murgo AJ, Doroshow JH. Phase I trial of fenretinide lym-x-sorb oral powder in adults with solid tumors and lymphomas. Anticancer Res. 2011 Mar;31(3):961-6. PMID 21498721