CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
GVAX pancreatic cancer vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00727441
NCT00727441Phase 2Completed

A Randomized Three-arm Neoadjuvant and Adjuvant Feasibility and Toxicity Study of a GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine Administered Either Alone or in Combination With Either a Single Intravenous Dose or Daily Metronomic Oral Doses of Cyclophosphamide for the Treatment of Patients With Surgically Resected Adenocarcinoma of the Pancreas

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 4, 2008·Updated Feb 25, 2020

In Brief

A Phase 2 clinical trial evaluating GVAX pancreatic cancer vaccine and cyclophosphamide for Pancreatic Cancer. Completed, enrolled 87 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is more effective with or without cyclophosphamide in treating patients with pancreatic cancer. PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given with or without cyclophosphamide in treating patients undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that can be removed by surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 4, 2008
Enrollment StartJul 2, 2008
Primary CompletionMay 1, 2015
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 17.9 years ago

Interventions

GVAX pancreatic cancer vaccinebiological

Given intradermally

cyclophosphamidedrug

Given IV (Arm B), given orally (Arm C)