Track topics on Twitter Track topics that are important to you
The purpose of this study is to test if interleukin-2, a drug that stimulates the immune system, can be used after chemotherapy to slow the progression of your disease. We also want to test what the best dose of interleukin-2 is that can be used safely at home.
Interleukin-2, abbreviated as IL2, is a naturally produced growth hormone for the immune cells in our body. It stimulates the growth of the immune cells and enhances their ability to fight infections and cancers. In people with cancer, the immune cells are typically suppressed and became even more so after irradiation and chemotherapy treatment. By giving you more IL2 we hope to enhance the immune system so that it can fight the cancer better, control cancer growth and shrink the cancer.
There are two treatment phases in this study. But before you begin in the study, we will need to find out whether you are eligible for the study. You will undergo the following procedures.
- Medical history review and physical exam
- Blood tests for hematology, chemistries, PSA, and immune assays (approximately 4 tablespoons of blood)
- CT scan of the abdomen and pelvis and a bone scan
- Complete a pain questionnaire, quality of life questionnaire, pain medication diary, and symptom diary
The initial treatment phase of this study consists of chemotherapy drug given weekly. You will receive 3 weekly chemotherapy treatments followed by 1 week with no treatment. Three weeks of treatment followed by one week of no treatment is considered 1 cycle, and you will receive a total of 4 cycles of chemotherapy over a 16-week period. Taxotere is given intravenously in the clinic on the 1st day of each weekly treatment.
Treatment with taxotere is a currently accepted treatment for this stage prostate cancer. Your doctor may recommend you receive taxotere even if you do not participate in this study. During this phase of treatment, you will have blood draws on treatment weeks prior to having the chemotherapy. You will have a PSA drawn every month (weeks 5, 9, and 13). We will ask you to complete a pain questionnaire, quality of life questionnaire, pain medication diary, and symptom diary at weeks 5, 9, and 13. Some of the questions may be personal, such as "I am satisfied with my sex life" and "I worry about dying". You do not have to answer these questions if you do not want to. You will also have a physical exam at the beginning of your 3rd cycle of treatment (week 9).
The second phase of the treatment program is the experimental part: immunotherapy with IL2. You will be assigned to receive one of 4 doses of IL2. This is because we are testing what is the highest dose of IL2 that a subject can receive without having unacceptable side affects from the IL2. You will give yourself shots of IL2 under the skin twice a day for 5 days per week for 3 weeks. During the 3rd week of treatment there are 2 days when you have to give a higher dose of IL2 for boosting the immune cells (see below diagram). The 4th week will be a rest week where you do not receive treatment. One 4-week period of IL2 treatment is called a cycle. You will continue to receive cycles of IL2 treatment as long as your cancer shows no further growth. We will teach you how to administer the IL2 at home.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Seattle Cancer Care Alliance
University of Washington
Published on BioPortfolio: 2014-08-27T03:46:25-0400
This study is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy. This study is designed to determine if...
The purpose of this study is to determine the effectiveness of two drugs, docetaxel and Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone therapy. The ...
The purpose of this study is to look at the effects (good and bad) of the combination of docetaxel and carboplatin for patients who have progressive prostate cancer after chemotherapy with...
This study will review the safety of picoplatin, a new type of platinum drug, with docetaxel, a drug commonly used in the treatment of prostate cancer. Patients who are eligible for this ...
The primary objective of the study is to determine a recommended phase II dose (RP2D). The secondary objective of the study are: 1. To evaluate preliminary incidence and duration of cl...
The aim of this study was to compare the efficacy and safety of docetaxel, cabazitaxel, docetaxel + estramustine, mitoxantrone in the management of castration-resistant prostate cancer (CRPC).
High baseline YKL-40 serum levels are associated with drug resistance in several solid tumours. However, their role in predicting docetaxel (DOC) resistance in prostate cancer (PCa) is unknown.
The standard-of-care treatment for metastatic prostate cancer (PCa) is androgen deprivation therapy (ADT). Nevertheless, most of those tumors eventually relapse and develop into lethal castration-resi...
Docetaxel improves survival in patients with metastatic prostate cancer (PC). This randomized phase II trial aimed to assess the activity of weekly docetaxel with radiotherapy (RT) plus androgen depri...
Qualitative and Quantitative Assessment of Patient and Carer Experience of Chemotherapy (Docetaxel) in Combination with Androgen Deprivation Therapy (ADT) for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
Recent studies suggest that docetaxel plus androgen deprivation therapy can prolong survival among men with metastatic hormone-sensitive prostate cancer (mHSPC). However, as a cytotoxic therapy, there...
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
Tumors or cancer of the PROSTATE.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Diabetes Diabetes Endocrine Disorders Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several g...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...