Docetaxel Followed by Provenge in Metastatic Prostate Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Prostate Cancer

In brief

This clinical study will evaluate the role of combination therapy of docetaxel followed by Provenge 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 docetaxel followed by Provenge 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 6 cycles of docetaxel followed by Provenge. 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. 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. The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of chemotherapy plus vaccine. Tissue endpoints will include biopsies prior to first chemotherapy and first vaccine therapy and at the end of each 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: NCT02793765
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 despite androgen deprivation therapy (ADT) 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 and ≥50% above the minimum PSA reached during ADT or above the pre-treatment level, if no response was observed; OR
Progression of measurable lymph nodes (≥15 mm) or visceral lesion measureable per RECIST v1.1 criteria; OR
New bone lesions (>10 lesions total) appearing on bone scan/imaging compared with a prior 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), is receiving immunosuppressive chemotherapy for oncologic disorders, 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 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
Myocardial infarct or ventricular arrhythmia or stroke within a 6-month period prior to inclusion, ejection fraction (EF) <40%, or serious cardiac conduction system disorders

Where it is running

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

Full record on ClinicalTrials.gov

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