TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor

NCT ID: NCT03185429

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2019-06-30

Brief Summary

The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.

Detailed Description

20 gastrointestinal solid tumor subjects failed from at least one systemic therapy will be enrolled into the trial .Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1, 3, 5, 11,17,23,35,47. Before the first cell infusion, the subjects should undergo a non-myeloablative chemotherapy regimen of Cyclophosphamide 300mg/m2 iv. Radiologic tumor assessment will be repeated every 8 weeks during treatment, until time of progression. Treatment will continue until disease progression, intolerance of toxic , withdrawal from the study, study completion, or study termination.

Conditions

Tumor Gastric; Tumor, Colorectal

Study Design

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

Study Groups

Experimental

Drug:Cyclophosphamide

Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells

Group Type: EXPERIMENTAL

Tumor Specific Antigen-loaded Dendritic Cells

Intervention Type: BIOLOGICAL

Subjects will be given subcutaneous injection of 5.0x10\^6-1.0x10\^7 TSA-DC on week 1,3,5,11,17,23,35,47.

Cyclophosphamide

Intervention Type: DRUG

300 mg/m2 by vein before the first cell infusion.

Interventions

Tumor Specific Antigen-loaded Dendritic Cells

Subjects will be given subcutaneous injection of 5.0x10\^6-1.0x10\^7 TSA-DC on week 1,3,5,11,17,23,35,47.

Intervention Type: BIOLOGICAL

Cyclophosphamide

300 mg/m2 by vein before the first cell infusion.

Intervention Type: DRUG

Other Intervention Names

TSA-DC vaccine; Cytoxan

Eligibility Criteria

Inclusion Criteria

1. Be ≥18 and ≤75,no gender based;

2. Expression of HLA-A0201/1101/2402;

3. Histopathologic documentation of gastrointestinal solid tumors(stomach cancer or colorectal cancer ) concurrent with the diagnosis of metastatic disease, and the tumor is Measurable;

4. Patients must have adequate tissue (fresh or paraffin block) for DNA extraction, which is used for gene sequencing, and prognoses the tumor specific antigen in turn,can predict to have new tumor antigens with high affinity for MHC molecules;

5. Failure in conventional treatment， or though benefit from chemotherapy the patient can't tolerant subjectively;

6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 and an anticipate life expectancy of at least three months,be cooperate to adverse reactions monitoring and therapeutic evaluation of the treatment;

7. Participants of child-bearing potential must agree to use adequate contraceptive methods up to 12 months after the pretreatment;

8. Serology：Seronegative for HIV antibody,seronegative for hepatitis C antibody. Hematology：Absolute neutrophil count ≥ 1000/mm(3) without the support of filgrastim ,WBC ≥ 3000/mm(3)，lymphocyte count ≥ 800/mm(3)，Platelet count ≥ 100,000/mm(3)，Hemoglobin ≥ 9.0 g/dl Chemistry：Serum ALT/AST ≤ 2.5 times the upper limit of normal，Serum Creatinine ≤1.6 mg/dl，Total bilirubin < 1.5 mg/dl, except in patients with Gilbert s Syndrome who must have a total bilirubin < 3.0 mg/dl;

9. Patients or their legal representatives are willing and able to understand and written informed consent form for the trial;

Exclusion Criteria

1. Is pregnant or breastfeeding,or expecting to conceive;

2. Have a history of severe immediate hypersensitivity reaction to any of the agents used in this study.

3. Suffered grade 3-4 major organ immune-related adverse events after anti-PD1/PDL1 antibody treatment.

4. Once received allogeneic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, except for corneal transplantation);

5. Have clinical symptoms of central nervous system metastases;

6. Have used a large number of glucocorticoids or other immunosuppressive agents within 4 weeks;

7. Have any active autoimmune disease ;

8. Be in active infection or undergo an unknown cause fever> 38.5 ℃ during screening or before the first administration(except tumor fever which evaluated by the researchers have no effect to enrollment );

9. Received chemotherapy or small molecule targeted drug therapy in 4 weeks prior to chemotherapy pretreatment;

10. Received any antibody drug therapy (including PD-1 and CTLA-4) within 6 weeks before the treatment period;

11. Severe liver and kidney dysfunction or uncontrollable diabetes, hypertension and other chronic systemic diseases; severe coagulation disorders, mental illness, cardiopulmonary disease，hydrothorax or ascites;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

BGI, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ZengQing Guo, Professor

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Central Contacts

Yu Chen, Doctor

Role: CONTACT

fannychenling05@sina.com

13859089836

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25837513 (View on PubMed)

Other Identifiers

BGI-002

Identifier Type: -

Identifier Source: org_study_id