Study of CellCept for Advanced Pancreatic Cancer

Status Completed

Clinical Trial Summary

Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to prevent the body's immune system from attacking transplanted organs. It has never been studied in patients with pancreatic cancer but some preliminary studies have shown that it may antagonize tumor growth. The goals of this study are to find out how much of this drug can safely be taken by patients with advanced pancreatic cancer and to assess the variation of the level of the drug in the blood. Patients will take the drug twice a day at a given dose and the safety of the drug will be monitored through patient symptoms and blood tests. The disease burden will be assessed by radiographic studies at the beginning and end of the study. The patient will take the drug for a total of eight weeks.

Clinical Trial Description

Mycophenolate Mofetil (CellCept) is a prodrug whose active metabolite, mycophenolic acid (MPA), acts as an immune suppressant by inhibiting de novo guanosine synthesis. CellCept is FDA approved to prevent rejection of transplanted organs. It is well tolerated, orally dosed, and has some known antitumor effects. It has never been studied in pancreatic cancer and the maximum tolerated dose is not known. In vitro studies in our lab with human pancreatic cancer lines found that MPA was a potent inhibitor of pancreatic cancer cell growth and induced apoptosis. The objectives of this study are to identify the maximum tolerated dose of CellCept in patients with advanced pancreatic cancer that have failed at least two prior chemotherapy regimens and assess its pharmacokinetics. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00997958
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	Phase 1
Start date	June 2004
Completion date	January 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05305001` - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed	`NCT02526017` - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers	Phase 1
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Recruiting	`NCT06054984` - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT04927780` - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer	Phase 3
Recruiting	`NCT05919537` - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation	Phase 1
Terminated	`NCT03140670` - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy	Phase 2
Terminated	`NCT00529113` - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer	Phase 1
Recruiting	`NCT05168527` - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients	Phase 2
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05391126` - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care	N/A
Terminated	`NCT03300921` - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer	Phase 1
Completed	`NCT03153410` - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas	Early Phase 1
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Recruiting	`NCT05679583` - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer	Phase 2
Recruiting	`NCT04183478` - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer	Phase 2/Phase 3
Terminated	`NCT03600623` - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT04584008` - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics	N/A
Recruiting	`NCT05351983` - Patient-derived Organoids Drug Screen in Pancreatic Cancer	N/A
Completed	`NCT04290364` - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study