View Trial - USC/Norris Cancer Center Clinical Trials

Details for trial 0C-05-8

Description:	A Phase I Study of IV Fenretinide in Patients with Malignant Solid Tumors.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Jacek Pinski	MD,PHD

Data Management

Name	Title
Claire Hughlett	R.N.
Gamaliel Jacinto	D.M.
Mary Ordaz	D.M.
Xiomara Menendez	R.N.

You may participate in this study if:

	Requirement
1	Patient 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.
2	Patient must have measurable disease documented by CT, MRI, OR non- measurable disease documented by Physical Exam within 28 days prior to registration.
3	Age 18 years and above.
4	ECOG performance status 0-2.
5	Life expectancy of greater than 3 months.
6	ANC more than or equal to 1,500; Leukocytes more than or equal to 3,000; Platelets more than or equal to 75,000.
7	Total 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
8	Serum creatinine WNL or Creatinine clearance more than 60 mL/min/1.73 m2
9	Effects 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.
10	Ability to understand and the willingness to sign a written informed consent document.
11	Patient 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:

1	Patient 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.
2	Patient receiving any other investigational agents.
3	Patient with an allergy to egg.
4	Patient 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.
5	Patient 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.
6	Patient had any major surgery within 2 weeks.
7	Uncontrolled 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.
8	Pregnant 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.
9	HIV-positive patient receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with fenretinide.
10	Hypertriglyceridemia uncontrolled by medication (>500 mg/dl).
11	Patient 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, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.