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Provenge (Sipuleucel-T) - Summary

 
 



PROVENGE SUMMARY

PROVENGE consists of autologous peripheral blood mononuclear cells, including antigen presenting cells (APCs), that have been activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator. The patient's peripheral blood mononuclear cells are obtained via a standard leukapheresis procedure approximately 3 days prior to the infusion date. Due to the autologous nature of PROVENGE, it is important that the patient and physician adhere to the personalized leukapheresis and infusion schedules. The active components of PROVENGE are autologous APCs and PAP-GM-CSF. During culture, the recombinant antigen can bind to and be processed by APCs into smaller protein fragments. The recombinant antigen is designed to target APCs, and may help direct the immune response to PAP. Minimal residual levels of the intact PAP-GM-CSF are detectable in the final PROVENGE product.

PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
See all Provenge indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Provenge (Sipuleucel-T)

Primary Care of Prostate Cancer Survivors
Source: Medscape Family Medicine Headlines [2014.08.14]
The American Cancer Society's new guidelines outline what the primary care clinician needs to know to provide optimal care to prostate cancer patients and survivors.
Medscape Oncology

Prostate Cancer Survivors Need Well-Rounded Care
Source: Medscape Hematology-Oncology Headlines [2014.08.14]
Dr. Gerald Chodak discusses a new report from the American Cancer Society that provides guidance on long-term care for men who have been diagnosed with prostate cancer.
Medscape Urology

Physician Approaches to Prostate Cancer Vary Widely
Source: Medscape Hematology-Oncology Headlines [2014.08.12]
Dr. Gerald Chodak asks how clinicians can provide a more standardized approach to low-risk prostate cancer.
Medscape Urology

HIFU for Prostate Cancer: Efficacy Data 'Lacking'
Source: Medscape Hematology-Oncology Headlines [2014.08.11]
Dr. Gerald Chodak discusses an FDA panel's recent recommendation against approving high-intensity focused ultrasound (HIFU) for the treatment of prostate cancer.
Medscape Urology

Routine prostate cancer screening 'reduces deaths but leads to overdiagnosis'
Source: Primary Care / General Practice News From Medical News Today [2014.08.07]
Long-term results of a major European study reveal that prostate cancer screening reduces deaths by more than 20%, but researchers say it is still too soon for routine screening.

more news >>

Published Studies Related to Provenge (Sipuleucel-T)

Cancer immunotherapy: sipuleucel-T and beyond. [2011.08]
In April 2010, sipuleucel-T became the first anticancer vaccine approved by the United States Food and Drug Administration. Different from the traditional chemotherapy agents that produce widespread cytotoxicity to kill tumor cells, anticancer vaccines and immunotherapies focus on empowering the immune system to overcome the tumor.

Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. [2011.07.01]
CONCLUSIONS: No significant difference in time to BF could be shown. The finding of increased PSADT in the sipuleucel-T arm is consistent with its biologic activity in ADPC. Long-term follow-up will be necessary to determine if clinically important events, such as distant failure, are affected by therapy. Treatment was generally well tolerated.

Sipuleucel-T: in metastatic castration-resistant prostate cancer. [2011.01.01]
Sipuleucel-T is an autologous active cellular immunotherapy used in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC)... infusion-related events, such as chills and fever) generally occurred within the first day after administration of sipuleucel-T and resolved within 2 days.

Cancer immunotherapy: sipuleucel-T and beyond. [2011]
In April 2010, sipuleucel-T became the first anticancer vaccine approved by the United States Food and Drug Administration. Different from the traditional chemotherapy agents that produce widespread cytotoxicity to kill tumor cells, anticancer vaccines and immunotherapies focus on empowering the immune system to overcome the tumor.

Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. [2011]
randomized, controlled studies in patients with prostate cancer... CONCLUSIONS: Sipuleucel-T therapy in patients with prostate cancer has a side

more studies >>

Clinical Trials Related to Provenge (Sipuleucel-T)

Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer [Recruiting]
The main purpose of this study is to determine whether ADT started before or after sipuleucel-T leads to a better immune system response. This study will also evaluate the safety of sipuleucel-T treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.

Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402) [Recruiting]
This study is being conducted to examine the immune response generated by sipuleucel-T in subjects previously treated with sipuleucel-T in the androgen dependent setting. The study will also assess the safety of receiving up to 3 additional infusions of sipuleucel-T. This is an open-label, uncontrolled, multicenter study, conducted in up to 14 clinical trial sites. The anticipated duration of the study is approximately 6 years.

Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer [Recruiting]
Background:

- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a

person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment.

Objectives:

- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate

cancer.

Eligibility:

- Men at least 18 years of age who have advanced prostate cancer.

Design:

- Participants will be screened with a medical history, physical exam, blood and urine

tests, and imaging studies.

- This study has two parts, with different participants in each part. All participants

will be monitored with frequent blood tests and imaging studies.

- Part I:

- Participants will provide cells for the Sipuleucel-T treatment three times. The first

time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy.

- Participants will have one dose of cyclophosphamide the day before the first dose of

Sipuleucel-T.

- Participants will have Sipuleucel-T about 3 days after each cell donation.

- Part II:

- Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or

given with both cyclophosphamide and CT-011.

- Participants will provide cells for the Sipuleucel-T treatment three times, as in Part

I.

- Participants will have Sipuleucel-T about 3 days after each cell donation, and will

receive treatment with the other drugs as directed by the study doctors.

Concurrent Versus Sequential Treatment With Sipuleucel-T and Abiraterone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC) [Recruiting]
The purpose of this study is to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T, and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.

Sipuleucel-T Manufacturing Demonstration Study [Recruiting]
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

more trials >>

Reports of Suspected Provenge (Sipuleucel-T) Side Effects

Asthenia (40)Chills (37)Fall (33)Anaemia (32)Disease Progression (31)Fatigue (31)Malaise (30)Hypotension (28)Nausea (26)Dehydration (26)more >>


Page last updated: 2014-08-14

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