Direct Tumor Injection KLH-Pulsed Dendritic Cells in Unresectable Pancreatic Cancer

NCT00868114 | Terminated Phase 2 DMC

• 2 other identifiers: LJCC 09-01RCA115018B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This research study uses radiation or a gene therapy agent, TNFerade in addition to a dendritic cell vaccine in patients with locally advanced or low volume metastatic pancreatic cancer. The use of TNFerade or radiation serves to generate cell death stimulating the immune response. The dendritic cell vaccine may direct a distant and lasting effective anti-tumor immune response to achieve a local and systemic clinical benefit.

Conditions

Metastatic Pancreatic Cancer

Keywords

Inoperable pancreatic cancer; Dendritic Cell Vaccine; Locally advanced or low volume metatstatic pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Patients will be followed until death

Study Arms (2)

1

EXPERIMENTAL

3 weekly injections of intratumoral TNFerade plus radiation and 3 weekly intratumoral injections of dendritic cell vaccine

Biological: KLH-pulsed autologous dendritic cell vaccine

2

EXPERIMENTAL

Radiation Only with 3 weekly intratumoral injections of dendritic cell vaccine

Biological: KLH-pulsed autologous dendritic cell vaccine

Interventions

KLH-pulsed autologous dendritic cell vaccine BIOLOGICAL

5 X10e7 KLH-pulsed autologous dendritic cell vaccine once weekly times three weeks

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven, unresectable pancreatic cancer with an intact primary tumor that is accessible to direct intratumoral injection
• Low volume metastatic disease defined as 1) radiographically occult disease discovered at the time of anticipated resection or 2) no more than 4 radiographically detected metastasis none of which are greater than 2 cm in greatest dimension
• Good overall health with a Karnofsky performance status of 70% or greater
• No evidence or history of an autoimmune dysfunction
• Life expectancy \> 3 months
• Agreement to initiate and complete standard treatment (chemotherapy ± radiation) for pancreatic cancer at the completion of the study
• Age equal to or greater than 18 years
• No prior or concurrent chemotherapy
• No previous or concurrent immunotherapy for pancreatic cancer
• Liver enzymes ≤ 3 times upper limit of normal:
• Tbili ≤ 3.9 (biliary stents are allowed)
• AST ≤ 177
• ALT ≤ 198
• Alk phos ≤ 378
• Adequate pretreatment organ function:

You may not qualify if:

• Prior history of XRT to primary pancreatic tumor
• Patients with tumors that are not accessible to direct access cannot be included in the study, nor will patients with poor overall health as determined by standard laboratory data and performance scales
• Prior or concurrent chemotherapy
• Prior history (within last four weeks) of antineoplastic therapy or irradiation
• Prior treatment with anti-tumor vaccines not allowed
• Patients with a history of autoimmune diseases such as SLE, rheumatoid arthritis or myasthenia gravis
• A history of HIV infection, AIDS or other immunosuppressive disease state
• Patients requiring regular corticosteroids within the past year are ineligible. There must be no use of corticosteroids in the fours weeks preceding entry into the study
• Active bacterial, fungal or viral infection
• Active bleeding (hemoptysis, melena, etc)
• Women who are currently pregnant or actively breast feeding. Women of childbearing potential must have a negative serum pregnancy test and must use effective contraception during trial participation
• Uncontrolled or unstable medical conditions, including angina, bronchospasm, hypertension, hyperglycemia, hypercalcemia and cardiac arrhythmia
• Any medical or psychiatric illness which in the opinion of the principal investigator might compromise a patient's ability to tolerate or complete treatment
• Patients requiring anticoagulation are ineligible
• Refusal to receive standard treatment (chemotherapy ± radiation) after the completion of the protocol

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

East Carolina University - Leo W. Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Emmanuel E Zervos, MD

  East Carolina University - Leo W. Jenkins Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: July 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2015
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

US (1)