Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer

NCT ID: NCT00547144

Last Updated: 2012-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-04-30

Brief Summary

To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer

Conditions

Pancreatic Cancer

Study Design

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

Study Groups

Gemcitabine

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1000 mg/m2 intravenoulsy once a week according to protocol schedule

Dendritic Cell Immunotherapy

Intervention Type: PROCEDURE

The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)

Interventions

Gemcitabine

1000 mg/m2 intravenoulsy once a week according to protocol schedule

Intervention Type: DRUG

Dendritic Cell Immunotherapy

The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)

Intervention Type: PROCEDURE

Other Intervention Names

Gemzar; DC Therapy; Dendritic Cell Therapy

Eligibility Criteria

Inclusion Criteria

2. Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.

3. Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study 4. More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.

5. Life expectancy of >3 months. 6. Karnofsky performance status >70%. 7. Patients must have normal organ and marrow functions as defined below: absolute neutrophil count >1,500/mm3 platelets >70,000/mm3 total bilirubin <1.5 mg/dL AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance >60mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

albumin > 2.8 mg/dL 8. Patients must have adequate clotting function (platelet > 70k; INR<1.4; PTT<60).

9. Age >18 years. 10. The effects of DCs on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria

2. Patients who have received prior gemcitabine or radiation therapy to the pancreatic bed 3. Patients receiving any other investigational agents. 4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.

5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.

6. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.

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

Sponsors

George Albert Fisher

OTHER

Sponsor Role: lead

Responsible Party

George Albert Fisher

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edgar G Engleman

Role: PRINCIPAL_INVESTIGATOR

Stanford University

George Albert Fisher M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

95935

Identifier Type: OTHER

Identifier Source: secondary_id

1454

Identifier Type: OTHER

Identifier Source: secondary_id

PANC0003

Identifier Type: -

Identifier Source: org_study_id

NCT00568932

Identifier Type: -

Identifier Source: nct_alias