|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | NewLink Genetics Corporation |
|---|---|
| Information provided by (Responsible Party): | NewLink Genetics Corporation |
| ClinicalTrials.gov Identifier: | NCT01072981 |
Purpose
The purpose of this study is to assess overall survival after treatment with a regimen of adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical resection.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Biological: HyperAcute-Pancreas Immunotherapy Drug: Gemcitabine Radiation: 5FU Chemoradiation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreas (Algenpantucel-L) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer |
| Estimated Enrollment: | 722 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immunotherapy + Standard of Care
*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation + HyperAcute Immunotherapy
|
Biological: HyperAcute-Pancreas Immunotherapy
Up to 18 immunizations of 300 million immunotherapy cells
Other Name: HAPa-1 and HAPa-2 immunotherapy components
Drug: Gemcitabine
Gemcitabine 1000 mg/m2/day once a week for 3 weeks
Other Name: Gemzar
Radiation: 5FU Chemoradiation
5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
Other Name: Fluorouracil
|
|
No Intervention: Standard of Care alone
*Adjuvant Standard of Care Treatment (SOC) consisting of gemcitabine with or without 5FU chemoradiation Alone
|
Drug: Gemcitabine
Gemcitabine 1000 mg/m2/day once a week for 3 weeks
Other Name: Gemzar
Radiation: 5FU Chemoradiation
5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
Other Name: Fluorouracil
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 61 Study Locations| Study Director: | Nicholas N Vahanian, M.D. | NewLink Genetics Corporation |
More Information
| Responsible Party: | NewLink Genetics Corporation |
| ClinicalTrials.gov Identifier: | NCT01072981 History of Changes |
| Other Study ID Numbers: | NLG0405, OBA# 0912-1013 |
| Study First Received: | February 18, 2010 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Pancreatic Cancer Vaccine Therapy |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Fluorouracil Gemcitabine Pancrelipase Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Radiation-Sensitizing Agents |