Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00387504
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor malignancy
* Metastatic and/or unresectable disease
* No standard curative or palliative measures exist or remain effective
* Measurable or evaluable disease
* No known brain metastases unless previously resected or irradiated with no treatment with steroids for more than 1 month
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 3 months
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 75,000/mm³
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with known liver metastases)
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception prior to, during, and for ≥ 6 months after completion of study treatment
* No uncontrolled diabetes mellitus at high risk for hypertriglyceridemia (i.e., fasting serum glucose concentration \> 200 mg/dL OR hemoglobin A1C \> 7.5%)
* No egg allergy
* No history of allergic reactions to compounds of similar chemical or biologic composition to fenretinide (e.g., isotretinoin, vitamin A, or tretinoin)
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would preclude compliance with study requirements
* No known hypertriglyceridemia requiring medication
* No identified familial hyperlipidemia disorder
PRIOR CONCURRENT THERAPY:
* Recovered from all prior therapy
* Prior treatment with oral fenretinide is allowed provided no severe toxicity occurred
* At least 2 weeks since prior major surgery
* More than 4 weeks since prior chemotherapy or radiotherapy
* At least 6 weeks since prior nitrosoureas or mitomycin C
* No other concurrent investigational agents
* No other concurrent anticancer chemotherapy
* No other concurrent antioxidants\*
* No concurrent hormone-ablative agents, including steroids, except for adrenal replacement or anti-inflammatory indications
* No other concurrent anticancer agents or therapies
* No concurrent herbal or other alternative therapies\*
* No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E)\*
* Standard-dose multivitamin allowed
* No other concurrent medications that may act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, p-glycoprotein, multidrug resistance protein 1 (MRP1), or MRP1 drug/lipid transporters, including any of the following\*:
* Cyclosporine or any of its analogues
* Verapamil
* Tamoxifen or its analogue
* Ketoconazole
* Chlorpromazine
* Mifepristone
* Indomethacin
* Sulfinpyrazone NOTE: \*Patients who have discontinued these drugs for ≥ 1 week are eligible
* No concurrent medications that may cause pseudotumor cerebri, including any of the following:
* Tetracycline
* Nalidixic acid
* Nitrofurantoin
* Phenytoin
* Sulfonamides
* Lithium
* Amiodarone
* No concurrent total parenteral nutrition (TPN) with intralipids
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00387504
Study Brief:
Protocol Section:
NCT00387504