Viewing Study NCT00450619



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00450619
Status: COMPLETED
Last Update Posted: 2017-01-04
First Post: 2007-03-20

Brief Title: 153Sm-EDTMP With or Without a PSATRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: A Randomized Phase 25 Study of 153Sm-EDTMP Quadramet With or Without a PSATRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer
Status: COMPLETED
Status Verified Date: 2016-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background

No treatment is known to improve survival for prostate cancer patients who have not been helped by previous treatments with hormones and chemotherapy
An experimental vaccine called prostate specific antigen PSATRICOM contains genes for a protein produced by prostate cancer cells called prostate-specific antigen PSA The vaccine can trigger the immune system to make cells that may be able to recognize and attack the cancer cells that make PSA
Granulocyte macrophage colony stimulating factor GM-CSF is an approved drug that is usually given to increase a patients white blood cell count or to stimulate the immune system
1Samarium-153-ethylene diamine tetramethylene phosphonate 53Sm-EDTMP is a radioactive drug that has been approved for many years to treat advanced prostate cancer It is given through a vein and can be targeted directly to tumors in the bone where it can relieve pain caused by bone lesions Radiation also increases the level of certain proteins inside the tumor making it easier for the immune system to find and kill the tumor cells
When laboratory mice were given just vaccine just radiation or a combination of both the combination was most effective in treating tumors

Objectives

-To determine if combined treatment with PSATRICOM vaccine and 153Sm-EDTMP radiation can delay progression of prostate cancer better than radiation alone

Eligibility

-Patients who have advanced prostate cancer that has worsened despite treatments with hormones have two or more bone lesions related to their prostate cancer and have had prior treatment with docetaxel chemotherapy

Design

Patients are randomly assigned to receive radiation alone Arm A or radiation with vaccine and sargramostim Arm B
Arm A receives 153Sm-EDTMP radiation starting on study day 8 and repeated every 12 weeks
Arm B receives a priming vaccine on study day 1 and radiation on day 8 Radiation therapy is repeated every 12 weeks Boosting vaccines are given on days 15 and 29 and then monthly GM-CSF is given with each vaccination on the day of the vaccination and for the next 3 days to enhance the immune response Vaccinations and GM-CSF are given as injections under the skin usually in the thigh Radiation therapy is given through a vein
Patients are monitored regularly with physical examinations blood and urine tests and scans to evaluate safety and treatment response
Patients who are human leukocyte antigen serotype within HLA-A A serotype group HLA-A2-positive undergo apheresis a procedure similar to donating blood for obtaining immune cells called lymphocytes to measure the immune response to the vaccine
Detailed Description: Background

There are no standard therapy options shown to prolong survival for patients with progressive disease on first-line docetaxel-based regimens for men with metastatic castration resistant prostate cancer CRPC
Ninety percent of men in this population have bone metastasis
PSATRICOM vaccines as single agents can induce generation of PSA-specific T cells in the majority of patients and objective responses and PSA declines in a minority of patients Furthermore the generation of at least a 6-fold increase in PSA-specific T cells was significantly correlated with evidence of clinical benefit
Radiation can alter the phenotype of tumor cells increase Fas increase major histocompatibility complex MHC increase tumor-associated molecules and increase ICAM making them much more amenable to immune-mediated killing
153Sm EDTMP is a beta emitter with some gamma emissions that targets osteoblastic bone lesions such as those found in prostate cancer
153Sm EDTMP at Food And Drug Administration FDA-approved doses used clinically for palliation of prostate cancer can cause phenotypic changes in tumor cells leading to improved killing of those cells in a cytotoxic T-cell assay in vitro
The combination of vaccine and radiation greatly increases antitumor efficacy in a murine subcutaneous tumor model

Objectives

Primary-A comparison of progression-free survival at 4 months between Arm A 153Sm EDTMP alone and Arm B 153Sm EDTMP with vaccine
Secondary-Objective responses PSA outcomes immunologic responses toxicity palliation and overall survival

Eligibility

Patients with metastatic CRPC who have 2 or more bone lesions consistent with prostate cancer and who have been treated with a docetaxel-based regimen
Patients with symptomatic soft tissue disease or parenchymal disease will be excluded

Design

Randomized phase 25 study
Sixty-eight patients to be enrolled and randomized to

Arm A 153Sm-EDTMP 1 mCikg intravenous IV over one minute on day 8 153Sm-EDTMP will be repeated every 12 weeks if there is adequate hematologic recovery

Arm B PROSTAC-VTRICOM vaccinia 2 x 108 plaque forming unit pfu subcutaneously on day 1

153Sm-EDTMP 1 mCikg IV over one minute on day 8 153Sm-EDTMP will be repeated every 12 weeks if there is adequate hematologic recovery PROSTVAC-FTRICOM fowlpox 1 x 109 pfu subcutaneously on days 15 29 and then every 4 weeks

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link




07-C-0106 None None None