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Trial record 17 of 60 for:    PD-1 and breast cancer | Recruiting, Not yet recruiting, Available Studies

A Study of Combinations of D-CIK Immunotherapy And Anti-PD-1 In Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT02886897
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Jianchuan Xia, Sun Yat-sen University

Brief Summary:

Background: Combinations of dendritic and cytokine-induced killer cell (D-CIK) based adoptive immunotherapy and anti-PD-1 antibody may enhance the immune response and stop cancer cells from growing.

Objective: Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and anti-PD-1 antibody in patients with treatment-refractory solid tumors.

Methodology: Phase II clinical trial in patients with advanced metastatic hepatocellular carcinoma, renal cell carcinoma,bladder cancer,colorectal cancer,non-small-cell lung cancer,breast cancer and other solid cancers. The D-CIK was isolated from peripheral blood of participants,then activated,expanded and incubated with anti-PD-1 antibody before infusion. The enough number (1.0-1.5 *10^10 cells) of D-CIK were infused back into participants.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Renal Cell Carcinoma Bladder Cancer Colorectal Cancer Non-small-cell Lung Cancer Breast Cancer Biological: D-CIK and anti-PD-1 antibody Phase 1 Phase 2

Detailed Description:

Heparinized peripheral blood was obtained from participants over a 2-week period. PBMCs were separated by Ficoll-Hypaque gradient centrifugation, suspended in X-VIVO 15 serum-free medium, and culture with 1000 U/ml rhIFN-γfor the first 24 h, followed by stimulation with 100 ng/ml OKT3 , 1000 U/ml rhIL-2 and 100 U/ml IL-1α to activate the CIK.Dendritic cells were incubated with CIK. Fresh medium containing 1000 U/ml rhIL-2 was added every 2 days and the cell density was maintained at 2×10^6 cells/mL.D-CIK were harvested, washed, and resuspended after culture for 14 days. Before cell transfer,D-CIK were incubated with anti-PD-1 antibody,and a fraction of the D-CIK were collected to assess their number, phenotype, and viability of cells, and to test for possible contamination by bacteria, fungi, or endotoxins. Then, autologous D-CIK (1.0-1.5*10^10 cells) were transferred to patients via intravenous infusion. Generally, participants received at least 4 cycles of treatment at 2-week intervals or received doses until disease progression occurred. If the participants were disease-stable, additional cycles of maintenance treatment were eligible.

Participants will be evaluated for the safety, clinical activity and toxicity. The primary end point was the objective response for each participant at the time of D-CIK and anti-PD-1 infusion as assessed by RECIST. Peripheral blood of patients were also assessed for related cytokine using ELISPOT assays. Additional,the investigators will evaluate tumor markers in participants with clinical response/non-response by immunohistochemical staining of tumor sections from previous diagnostic or therapeutic biopsy samples to determine the predictive biomarker that may be used in future studies.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Combinations of Dendritic Cells and Cytokine-induced Killer Cell (D-CIK) Immunotherapy And Anti-Programmed Death-1 In Refractory Solid Tumors
Study Start Date : July 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: D-CIK and anti-PD-1 Immunotherapy
D-CIK was incubated with anti-PD-1 antibody before infused back into participants
Biological: D-CIK and anti-PD-1 antibody
Autologous dendritic and cytokine-induced killer cells (D-CIK)(1.0-1.5*10^10 cells)were incubated with anti-PD-1 antibody and infused into participants.




Primary Outcome Measures :
  1. Progress-free survival(PFS) [ Time Frame: 12 Months ]
    PFS is defined as the time from the combined therapy until objective tumor progression or death.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 12 Months ]
    OS is defined as the time from the combined therapy until death from any cause

  2. Laboratory findings [ Time Frame: 6 Months ]
    The number and secreted cytokines of CD3+ (or CD8+ or CD4+ or CD56+) T cells

  3. Objective response rate [ Time Frame: 12 Months ]
    The total number of Complete remission and Partial remission (According to the response criteria in solid tumor(RECIST))

  4. Severity of adverse events [ Time Frame: 12 Months ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participantswith treatment-refractory advanced hepatocellular carcinoma, renal cell carcinoma,bladder cancer,colorectal cancer,non-small-cell lung cancer,breast cancer and other solid cancers.
  • Age 18 to 75 years.
  • Willing to sign a durable power of attorney.
  • Able to understand and sign the Informed Consent Document.
  • Life expectancy of greater than three months.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen.
  • Adequate organ function.
  • Serology:

    • Seronegative for HIV antibody.
    • Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
  • Hematology:

    • WBC (> 3000/mm(3)).
    • Platelet count greater than 100,000/mm(3).
    • Hemoglobin greater than 8.0 g/dl.
  • Chemistry:

    • Serum ALT/AST less or equal to 2.5 times the upper limit of normal.
    • Serum creatinine less than or equal to 1.6 mg/dl.
    • Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

Exclusion Criteria:

  • Previous treatment with anti-CTLA-4 and anti-PD-1/PD-L1.
  • Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  • History of autoimmune disease
  • Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  • Concurrent antineoplastic therapies and systemic steroid therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886897


Contacts
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Contact: Jian-Chuan Xia, Ph.D. 862087345699 xiajch@sysucc.org.cn
Contact: Yi-Xin Zeng, Ph.D. 862087343333 zengYX@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-Sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jian-Chuan Xia, Ph.D.    86-20-87345699    xiajch@sysucc.org.cn   
Contact: Fang-jian Zhou, Ph.D.    86-20-87343404    zhoufj@sysucc.org.cn   
Principal Investigator: Yi-Xin Zeng, Ph.D.         
Sub-Investigator: Jian-Chuan Xia, Ph.D.         
Sub-Investigator: Fang-jian Zhou, Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yi-Xin Zeng, Ph.D. Sun Yat-sen University

Publications of Results:
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Responsible Party: Jianchuan Xia, Director of Biotherapy;Principal Investigator;Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02886897     History of Changes
Other Study ID Numbers: B2016-036-01
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jianchuan Xia, Sun Yat-sen University:
Refractory solid tumors
Dendritic and Cytokine-induced killer cell
Anti-PD-1 antibody
Combination immunotherapy

Additional relevant MeSH terms:
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Colorectal Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Liver Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma