Trial 4P-09-9

A Phase I/II Trial of AN-152 [AEZS-108] in Castration- and Taxane-Resistant Prostate Cancer.

Type: Cancer Therapy
Phase: Phase I/II
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Jacek Pinski, MD,PHD
Other Trial Staff: Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Jolie Solomon, R.N., Carrie Korn, R.N., Francisco Acosta, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Histologically or cytologically confirmed prostate cancer
2	Measurable disease on CT or evaluable disease with an elevated PSA
3	Documented progression on (a) at least one prior hormone treatment, which must have incorporated LH-RH agonist therapy; and (b) at least one chemotherapy regimen, which must have been taxane-based
4	Palliative RT for metastatic disease allowed only if <25% of total body BM was irradiated and <35 Gy administered to pericardial area. 28 days must have elapsed since completion of RT with BM recovery. Soft tissue disease irradiated in the prior 2 months may not be designated as measurable disease.
5	At least 18 years of age
6	Life expectancy at least 3 months
7	ECOG performance score 0-2
8	AGC = / > 1.0; Hgb = / > 8.0; platelets = / > 75,000
9	Bilirubin < / = 1.5 mg/dl and alk phos < / = 3 x uln (< / = 5 x uln if with known hepatic mets and no limit for patients with known bone mets) and SGOT & SGPT < / = 3 x uln (< / = 5 x uln if with known hepatic mets)
10	Creatinine < / = 1.5 x uln
11	Recovered from acute and late effects of any prior surgery, RT, or other anti-neoplastic therapy
12	Men of childbearing potential must use barrier contraception while on treatment and for 90 days thereafter
13	Willing to discontinue LHRH analogue therapy for the duration of the study
14	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Ongoing use of an LH-RH agonist (or antagonist). Patients who agree to stop LH-RH agonist therapy will be eligible but may need to wait until their required washout period is over. Patients whose washout period is > 6 weeks will not be eligible.
2	Active infection or fever >38.5C within 3 days of the first scheduled protocol treatment
3	Parenchymal brain mets. Patients with neurological symptoms must have a CT or MRI of the brain showing no metastases within 60 days of enrollment.
4	History of prior malignancy within the past 5 years, except curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder
5	Known hypersensitivity to any of the components of AN-152 including doxorubicin and LH-RH agonists
6	Prior RT within 4 weeks of entry
7	Prior treatment with strontium-89 or samarium-153
8	Prior treatment with sipuleucel-T (Provenge) in the past 3 months
9	History of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or CHF or recent MI within 6 months of enrollment
10	LVEF <50%
11	Prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone
12	Major surgery within the last 2 weeks
13	Concurrent investigational therapy or prior investigational therapy within 30 days of the first scheduled day of protocol treatment
14	Known HIV or hepatitis B or C infection
15	Presence of any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results
16	Prior treatment with AN-152
17	Anticipated non-availability for study visits/procedures

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.