University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 0C-05-8


A Phase I Study of IV Fenretinide in Patients with Malignant Solid Tumors.

Type: Treatment
Phase: Phase I
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Retinoids
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Jacek Pinski, MD,PHD
Other Trial Staff:  Mary Ordaz, D.M., Anayansi Miloud, D.M., Xiomara Menendez, R.N., Jubilee Acap, R.N.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Patient must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
2Patient must have measurable disease documented by CT, MRI, OR non- measurable disease documented by Physical Exam within 28 days prior to registration.
3Age 18 years and above.
4ECOG performance status 0-2.
5Life expectancy of greater than 3 months.
6ANC more than or equal to 1,500; Leukocytes more than or equal to 3,000; Platelets more than or equal to 75,000.
7Total bilirubin less than 1.5 x IULN; AST (SGOT) less than or equal to 2.5 x IULN ; ALT (SGPT) less than or equal to 3 x IULN
8Serum creatinine WNL or Creatinine clearance more than 60 mL/min/1.73 m2
9Effects of fenretinide on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
10Ability to understand and the willingness to sign a written informed consent document.
11Patient who received prior treatment with oral fenretinide is eligible, provided he/she did not experience severe toxicity related to treatment.


You may not participate in this study if:
1Patient had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
2Patient receiving any other investigational agents.
3Patient with an allergy to egg.
4Patient with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide, such as 13-cis-retinoic acid, retinol, or all-trans-retinioic acid.
5Patient with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
6Patient had any major surgery within 2 weeks.
7Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
8Pregnant women are excluded from this study because the effects of fenretinide on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with fenretinide, breastfeeding should be discontinued if the mother is treated with fenretinide.
9HIV-positive patient receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with fenretinide.
10Hypertriglyceridemia uncontrolled by medication (>500 mg/dl).
11Patient concurrently taking the following drugs are excluded: antioxidants, herbal or other alternative therapy medications, vitamin supplements (especially vitamins A, C, and E), other than a standard dose multivitamin, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, and amiodarone.



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.