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

Leo W. Jenkins Cancer Center

Status and phase

Terminated

Phase 2

Conditions

Metastatic Pancreatic Cancer

Treatments

Biological: KLH-pulsed autologous dendritic cell vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT00868114

LJCC 09-01

RCA115018B

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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