• Return to search results
• Start new search

Investigator(s):
Anthony J.  Murgo, M.D., M.S. Principal Investigator Phone: 301-496-4291 murgoa@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Mary Ann Yancey, R.N. Research Nurse Phone: 301-435-9227 yanceym@mail.nih.gov	Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov

---

Primary Eligibility:

• Histologically confirmed diagnosis of one 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)
• Recovered from all prior therapies
• Patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible
• No concurrent sulfonamides, other investigational agents, other cancer chemotherapy or immunomodulating agents (including systemic corticosteroids), herbal supplements or other alternative therapy medications
• Patients must not take any drugs suspected of causing pseudo tumor cerebri
• ECOG 0–2 OR Karnofsky 60–100%
• ANC ≥ 1,500/μL
• Platelets ≥ 100,000/μL (CTCAE v.3 grade 1 thrombocytopenia allowed if explained by involvement of the bone marrow by lymphoma)
• Bilirubin ≤ 1.5 x normal institutional limits (2.5 mg/dL for patients with Gilbert’s syndrome)
• AST/ALT ≤ 2.5 x upper limit of normal (ULN)
• Creatinine < 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing; fertile patients must use two methods of birth control prior to, during, and for 2 months after completion of study treatment
• No clinically significant illness which could compromise participation in the study
• 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)

---

Treatment Plan:

This is a multicenter study.

• Patients receive oral fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) twice 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

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/28/08
Updated: 11/14/08