Trial 0C-05-5

A Phase I Trial of PXD101 in Combination with 13-cis-Retinoic Acid in Advanced Solid Tumor Malignancies.

Type: Cancer Therapy
Phase: Phase I
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Chemotherapy: Systemic
Randomized: No
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Trial Leaders/Researchers: Heinz Josef Lenz, M.D.
Other Trial Staff: Susan Edwards, R.N., Anayansi Miloud, D.M., Xiomara Menendez, R.N., Arthur Alvarez, D.M., Arthur Alvarez, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Patients must have histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
2	Age greater than or equal to 18 years.
3	ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 50%).
4	Life expectancy of greater than 3 months.
5	Patients must have normal organ and marrow function as defined below: - leukocytes greater than or equal to 3,000 - absolute neutrophil count greater than or equal to 1,500 - platelets greater than or equal to 100,000 - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal - creatinine within normal institutional limits OR - creatinine clearance greater than or equal to 60 mL/min for patients with creatinine levels above institutional normal.
6	Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of PXD101 will be determined following review of their case by the Principal Investigator.
7	The effects of PXD101 on the developing human fetus are unknown. For this reason and because 13-cRA and HDAC inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, 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 participating in this study, she should inform her treating physician immediately.
8	Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
9	Although not an eligibility criterion, it is recommended that patients have a central venous device (port-a-cath or PICC line).

You may not participate in this study if:

1	Patients who have 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	Patients may not be receiving any other investigational agents.
3	Patients with known brain metastases are 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.
4	History of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101 or other agents used in study.
5	Patients should not have taken valproic acid, another histone deacytelase inhibitor, for at least 2 weeks prior to enrollment.
6	Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
7	A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500 msec; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes.
8	Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
9	Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PXD101, breastfeeding should be discontinued if the mother is treated with PXD101. These potential risks may also apply to other agents used in this study.
10	HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with PXD101. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

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.