Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer (HST)

Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer

To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer Stage IV; Pancreatic Cancer Stage III
• Intervention / Treatment: Drug: Gemcitabine; Other: GPBSC

Detailed Description

Allogeneic hematopoietic stem cell transplantation has been successfully used for the treatment of hematopoietic malignancy. In recent years, non-myeloablative hematopoietic stem cell transplantation (NST) has been introduced to treat solid tumors due to the Graft-versus tumor effect. In this study, the investigators try to evaluate the safety and efficacy of NST in the treatment of unresectable pancreatic cancer patients.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 30000
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PET-CT/EUS-FNA cytologically confirmed stage III -Ⅳ of pancreatic cancer
• Between 18 and 80 years old
• Karnofsky Performance Status (KPS) ≥ 70%，Guaranteed treatment for 3 months
• Normal functions of heart, lung and kidney
• Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥ 1,500/mm^3 、Platelet count ≥ 100,000/mm^3， start the treatment within 14 days after these results meet the requirements
• A life expectancy > 3 months
• Informed consent signed
• HLA-haplotype-matched immediate family health donors who have been confirmed by laboratory HLA genotypes
• Interval the last anti-tumor treatment for more than 3 months

Exclusion Criteria:

• Highly allergic or people with severe allergies
• Brain metastasis or Primary central nervous system malignancy
• Suffer from clinical illnesses that affect clinical trials, including but not limited to： Uncontrollable diabetes；active infectious disease or uncontrollable infection; acute and chronic liver disease; confirmation of HIV infection; uncontrollable hypertension, symptomatic congestive heart-failure, unstable angina pectoris, and myocardial infarction, uncontrollable arrhythmia over the last 6 months.
• Combined heart, lung, kidney and other vital organs dysfunction
• A serious coagulation dysfunction, a clear history of other tumors
• Pregnant and lactating women
• Mental illness, affecting the compliance of clinical trials
• The patient will participate in other trials within 10 days prior to the trial or While participating in other tests
• Patients underwent weight loss by 10% and above within 6 weeks before the start of the trial
• Neutrophils<500mm^3 or Platelet count<50,000/mm^3
• Need to drive and manipulate the machine during the trial

Donor's Inclusion Criteria:

• First-degree relatives of patients
• Age<55 years old
• Normal functions of heart, lung and kidney
• Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥ 1,500/mm^3 、Platelet count ≥ 100,000/mm^3、WBC≥ 3000/mm^3， start collecting stem cells within 14 days after these results meet the requirements
• Informed consent signed

Donor's exclusion Criteria:

• Highly allergic or people with severe allergies
• The person who have history of atherosclerosis, venous thrombosis or autoimmune disease
• A serious coagulation dysfunction, a clear history of other tumors
• Infectious disease or carriers
• Pregnant and lactating women
• Mental illness, affecting the compliance of clinical trials
• WBC<4000/mm^3、PLT<70*10^9/L

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GEM plus GPBSC; Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg	Drug: Gemcitabine; Chemotherapy: Gemcitabine is administered Intravenous injection once a week，at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.; Other: GPBSC; immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.
Other: Gemcitabine	Drug: Gemcitabine; Chemotherapy: Gemcitabine is administered Intravenous injection once a week，at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.
Other: GPBSC	Other: GPBSC; immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival will be measured at 3 months after transplant.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	3 months
Overall survival (OS)	3 months
Response rate	3 months
Progression free survival（PFS）	3 months
Karnofsky Performance Status（KPS）	3 months

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Jihui Hao, MD, PHD, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: NST-01