WebService-ClinicalTrialsdotGov
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with stage IV breast cancer.
'
},
'location_countries' => {
'country' => 'United States'
},
'is_section_801' => 'Yes',
'secondary_outcome' => [
{
'time_frame' => '3 years',
'measure' => 'To determine if cellular and humoral immunity is induced by serial vaccination with DC/tumor fusion cells and rhIL-12.',
'safety_issue' => 'No'
},
{
'time_frame' => '3 years',
'measure' => 'To determine if vaccination with DC/tumor fusions and rhIL-12 results in clinically measurable disease responses.',
'safety_issue' => 'No'
}
],
'responsible_party' => {
'name_title' => 'David Avigan, MD',
'organization' => 'Beth Israel Deaconess Medical Center'
},
'eligibility' => {
'healthy_volunteers' => 'No',
'minimum_age' => '18 Years',
'criteria' => {
'textblock' => '
Inclusion Criteria:
- Stage IV breast cancer with measurable disease and accessible tumor
- ECOG Performance Status 0-2 with greater than six week life expectancy
- 18 years of age or older
- Laboratory values as outlined in the protocol
- Received a maximum of 2 prior chemotherapy regimens for metastatic disease and may
have had any number or prior hormonal treatments
Exclusion Criteria:
- Patients must not have received other immunotherapy treatment in the three months
prior to the initial vaccination
- Patients may not be on herceptin therapy during this protocol and may not have
received it for four weeks prior to initial vaccination
- Patients must not have received chemotherapy or hormonal treatment for four weeks
prior to the initial vaccination
- Clinical evidence of CNS disease
- Clinically significant autoimmune disease
- Patients who are HIV+
- Serious intercurrent illness such as infection requiring IV antibiotics, or
significant cardiac disease characterized by significant arrhythmia, ischemic
coronary disease or congestive heart failure
- Pregnant of lactating women will be excluded, all premenopausal women must undergo
pregnancy testing'
},
'maximum_age' => 'N/A',
'gender' => 'Female'
},
'phase' => 'Phase 1/Phase 2',
'lastchanged_date' => 'April 7, 2010',
'start_date' => 'December 2009',
'is_fda_regulated' => 'Yes',
'required_header' => {
'download_date' => 'Information obtained from ClinicalTrials.gov on November 04, 2010',
'url' => 'http://clinicaltrials.gov/show/NCT00622401',
'link_text' => 'Link to the current ClinicalTrials.gov record.'
},
'overall_contact_backup' => {
'email' => 'yyuan1@bidmc.harvard.edu',
'phone' => '617-667-1998',
'last_name' => 'Emily Yuan'
},
'condition' => 'Breast Cancer'
};
my $Study =
WebService::ClinicalTrialsdotGov::Study->new( $rh_study );
isa_ok( $Study, 'WebService::ClinicalTrialsdotGov::Study' );
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