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

NCT ID: NCT00868114

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

KLH-pulsed autologous dendritic cell vaccine

Intervention Type: BIOLOGICAL

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

2

Radiation Only with 3 weekly intratumoral injections of dendritic cell vaccine

Group Type: EXPERIMENTAL

KLH-pulsed autologous dendritic cell vaccine

Intervention Type: BIOLOGICAL

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

Interventions

KLH-pulsed autologous dendritic cell vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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:

• Creatinine no greater than 1.5mg/dL
• Total calcium no greater than 11.0mg/dL
• PT no greater then 14 seconds
• PTT no greater then 40 seconds
• Ability to give informed consent
• Adequate baseline hematopoietic function:

• Total white blood cell count equal to or greater than 3,000/mm3;
• Absolute granulocyte count greater than 1,500/mm3;
• Absolute lymphocyte count greater than 500/mm3;
• Platelet count equal to or greater than 100,000/mm3.

Exclusion Criteria

• 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
• Evidence of DVT or prior history of DVT

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: collaborator

Leo W. Jenkins Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel E Zervos, MD

Role: PRINCIPAL_INVESTIGATOR

East Carolina University - Leo W. Jenkins Cancer Center

Locations

East Carolina University - Leo W. Jenkins Cancer Center

Greenville, North Carolina, United States

Countries

United States

Other Identifiers

RCA115018B

Identifier Type: -

Identifier Source: secondary_id

LJCC 09-01

Identifier Type: -

Identifier Source: org_study_id