Immunochemoradiotherapy in Patients With Pancreatic Cancer

NCT01342224 | Completed Phase 1

• 1 other identifier: PHS 10-141B
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study will add an immunotherapy component to chemotherapy and radiation treatment in patients who have pancreatic cancer. The objective of this study is to see if the combined treatment is safe and feasible, and if a larger study is warranted.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

pancreatic; cancer; adenocarcinoma; vaccine

Outcome Measures

Primary Outcomes (1)

• Safety

  Adverse events will be graded no less than weekly for the first 180 days. Post-treatment long-term follow-up will occur every 12 weeks beyond day 180 for 6 visits and then every 24 weeks thereafter until progressive disease, withdrawal from study or death. For this pilot study, adverse events and efficacy measures will be personally reviewed by the principal investigator. Both hematologic and non-hematologic toxicity will be anticipated. In conjunction with the IRB, stopping the trial will be among possible measures taken if undue toxicity or inadequate outcomes are observed.

  180 Days

Secondary Outcomes (2)

• Immune Response

  18 months

• Tumor Response

  180 days

Study Arms (1)

tadalafil and vaccination

EXPERIMENTAL

Participants receive a 4-week course of vaccination with telomerase vaccine and GM-CSF by injection, along with a cycle of gemcitabine chemotherapy (IV). This is followed by radiation and gemcitabine given twice weekly then by another dose of vaccine.

Biological: tadalafil and vaccination

Interventions

tadalafil and vaccination BIOLOGICAL

Participants receive a 4-week course of vaccination with telomerase vaccine and GM-CSF by injection, along with a cycle of gemcitabine chemotherapy (IV). This is followed by radiation and gemcitabine given twice weekly then by another dose of vaccine. Four weeks after completion of chemotherapy and radiation, participants able to have surgical treatment will have surgery followed by vaccination and chemotherapy. Participants with stable or responsive disease that cannot be treated by surgery will have vaccination and chemotherapy with 2 cycles of telomerase vaccine with GM-CSF along with gemcitabine. Participants with unresectable and progressive disease after administration of vaccine, chemotherapy and radiation treatment may transition to vaccination and chemotherapy treatment.

Also known as: tadalafil: Cialis, gemcitabine: Gemzar, telomerase vaccine: GV1001, GM-CSF: Sargramostim (Leukine)

tadalafil and vaccination

Eligibility Criteria

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

You may qualify if:

• Borderline resectable pancreatic adenocarcinoma (any of the following):
• Tumor abutment or encasement of a short segment of hepatic artery (without evidence of tumor extension to the celiac artery) that is amenable to resection and reconstruction
• Tumor abutment of the superior mesenteric artery involving 180 degrees or less of the circumference of the artery and without encasement
• Impingement or narrowing of the superior mesenteric vein/portal vein or short-segment (\< 2 cm) occlusion of the superior mesenteric vein, portal vein, or their confluence with a suitable option for vascular reconstruction
• Eastern Cooperative Oncology Group(ECOG)Performance Status 0 or 1
• Ability to give informed consent and comply with the protocol
• Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment.
• Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.

You may not qualify if:

• Age \< 18 years
• History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
• Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation therapy to the target field
• Clinically active autoimmune disease or active infection
• History of heart attack (within 90 days) or stroke (within 6 months), or presence of hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (New York Heart Association (NYHA) Functional Classification ≥ Class 2 in last 6 months), unstable angina or angina occurring during sexual activity.
• Use of "nitrates" or nitroglycerin.
• History of hereditary degenerative retinal disorders including retinitis pigmentosa.
• Chronic systemic corticosteroid use at supra-physiologic doses (prednisone \> 10 mg a day or equivalent)
• Use of recreational drugs called "poppers" like amyl nitrite and butyl nitrite.
• Laboratory values (performed within 14 days prior to enrollment) as follows:
• Neutrophil count \< 1500 cells/µL
• Hemoglobin \< 9 gm/dL (patients may be transfused to establish eligibility)
• Platelet count \< 100,000 cells/µL
• Significant coagulopathy (INR \> 1.5)
• Significant liver or renal dysfunction

Sponsors & Collaborators

• Providence Health & Services: lead
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator
• Robert W. Franz Cancer Research Center: collaborator

Study Sites (1)

Providence Health & Services

Portland, Oregon, 97213, United States

Location

Related Publications (1)

• Crocenzi T, Cottam B, Newell P, Wolf RF, Hansen PD, Hammill C, Solhjem MC, To YY, Greathouse A, Tormoen G, Jutric Z, Young K, Bahjat KS, Gough MJ, Crittenden MR. A hypofractionated radiation regimen avoids the lymphopenia associated with neoadjuvant chemoradiation therapy of borderline resectable and locally advanced pancreatic adenocarcinoma. J Immunother Cancer. 2016 Aug 16;4:45. doi: 10.1186/s40425-016-0149-6. eCollection 2016.

  PMID: 27532020 DERIVED

MeSH Terms

Conditions

Neoplasms; Adenocarcinoma

Interventions

Tadalafil; Vaccination; Gemcitabine; sargramostim

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• Todd Crocenzi, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 27, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2018
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)