Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Prostate Cancer

In brief

This clinical study will evaluate the role of combination therapy of Provenge followed by docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate cancer that is resistant to medical or surgical treatments that lower testosterone). The purpose of this study is to look at the combination therapy of Provenge followed by docetaxel to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. The study drugs are approved by the Food and Drug Administration (FDA). Treatment will be administered on an outpatient basis. Patients will receive Provenge followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days). The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of vaccine plus chemotherapy. Tissue endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.

Key facts

Study ID

NCT02793219

Run by

The University of Texas Health Science Center, Houston

People needed

0

Starts

2016-12-01

Expected to finish

2021-07-01

Last updated by the study team

2017-10-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male 18 years and older.
• Pathologic confirmation of prostate adenocarcinoma.
• Asymptomatic or minimally symptomatic disease.
• Presence of skeletal or visceral/nodal metastasis confirmed by MRI, scintigraphy, or CT scan
• Disease progression as indicated by:
• PSA increase indicated by two consecutive higher values over baseline at assessments performed at least 7 days apart from each other in the previous 28 days with the absolute value ≥5 ng/ml; OR
• Progression of measurable lymph nodes (≥15 mm) measureable per RECIST v1.1 criteria; OR
• New bone lesions appearing on imaging compared with a prior bone scan. (Bone scan to be performed at screening or within the previous 28 days.)
• Maintenance of castrate conditions: Patients who have not had a surgical orchiectomy must continue with hormone therapy (GnRH/LHRH agonists or antagonists) to maintain levels of serum testosterone of <50 ng/dl.
• Patient is clinically immunocompetent. Clinical immunocompetence will be assumed unless a subject has been diagnosed as being immunosuppressed, is receiving oral steroids (nasal sprays and inhalers are permitted), or is receiving immunosuppressive therapy following transplant, in which case they will be excluded.
• Peripheral neuropathy grade ≤1.
• Laboratory criteria:
• Adequate bone marrow function:
• White blood cells ≥4000/mm3
• Absolute neutrophil count ≥1500/mm3
• Absolute lymphocyte count ≥500/µl
• Hemoglobin ≥10 g/dl
• Platelet count ≥100,000/mm3
• Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted)
• Renal function creatinine ≤1.5 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be within normal range.
• Life expectancy of at least 6 months based on Investigators' judgment
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• At least 4 weeks after surgery or radiotherapy
• If patients have been receiving bisphosphonate or denosumab, they can continue either medication.

You may not qualify if…

• Patient's disease burden is greater than the prognostic criteria defined earlier, including the presence of visceral or bone metastases.
• Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy >5 years previously and have no known evidence of residual or recurrent disease.
• Current symptomatic cord compression requiring surgery or radiation therapy
• Prior chemotherapy for prostate cancer
• Patient is using supplements or complementary medicines/botanicals. Patients should review the label with their doctor prior to enrolment. The following exceptions are permitted at screening and during the course of the study.
• Conventional multivitamin supplements
• Selenium
• Lycopene
• Soy supplements
• Vitamin E
• Fish oil supplements
• Vitamin D
• Glucosamine supplements
• Age-related eye disease vitamins
• Ginkgo biloba
• Patient co-morbidities:
• HIV positive
• Acute hepatitis B (HBV) or active hepatitis C (HCV)
• Clinical and laboratory evidence of active bacterial, viral, or fungal infection requiring systemic treatment
• Clinically significant cardiovascular disease including
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Serious cardiac arrhythmia requiring medication
• Uncontrolled hypertension >150/100mm Hg (if controlled with medication this is not an exclusion).
• Hypotension

Where it is running

• UTHealth Memorial Hermann Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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