Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Digital Colposcopy for Fluorescence (DCF)

As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.

Colposcopy

Michele Follen, MD, PhD

The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy.

Other Objectives:

* To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.
* To evaluate the effect of acetic acid in the image contrast obtained.
* Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.

DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).

DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.

Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.

This is an investigational study. About 114 women will take part in this study. About 22 will be enrolled at M. D. Anderson.

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

BIRC5 protein, human

The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment

autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens

autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens .

MASCT:Multiple Antigens Specific Cellular Therapy

To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group' in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in China.

Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).

Randomized, Open-label, Multi-center Clinical Trial to Compare the Efficacy and Safety of MASCT Group' and 'Non-treatment Group' in Patient Undergone Curative Resection( RFA or Operation) for Hepatocellular Carcinoma .MASCT That Expresses Multiple Antigens Specific Cellular Therapy,Autologous Immune Cytotoxic of T-lymphocytes(CTL) Induced by Dendritic Cell(DC) Loaded With Multiple Antigens

Nanfang Hospital, Southern Medical University

Third Affiliated Hospital, Sun Yat-Sen University

Sun Yat-sen University

Beijing 302 Hospital

Fujian Cancer Hospital

HRYZ Biotech Co.

Blood and Lymph Conditions

Immune System Diseases

Hematologic Neoplasms

Graft vs Host Disease

Hematologic Diseases

Homologous Wasting Disease

Infusion of donor dendritic cells

Infusion of donor lymphocytes

Edwin Alyea, MD

The purpose of this study is to test the safety of adding donor dendritic cells to donor lymphocyte infusions, and to determine the type and severity of any side effects associated with this addition. Previously patients with hematologic malignancies who relapsed after transplant have been given infusions of donor white blood cells (donor lymphocyte infusion, DLI) as a way to boost their immune function and fight disease. Although DLI has led to cancer regression in some patients, the overall response rate using DLI alone is low, and unfortunately, rarely lasting. Researchers have discovered a new subset of blood cells, called dendritic cells (DC), which are crucial partners to lymphocytes in generating an immune response. We believe that the infusion of DC together with DLI may improve the ability of the donor lymphocytes to recognize and kill cancer cells.

* Since we are looking for the highest dose of donor dendritic cells that can be administered safely with DLI patients after allogeneic stem cell transplant, not everyone who participates in this study will be receiving the same number of dendritic cells.
* The study procedure can be divided into 3 phases: 1) Pre-infusion evaluation, 2) Cell collections and infusions, 3) Follow-up after infusions.
* Pre-infusion evaluation: Routine blood tests will be performed on both the participant and donor. The participant will undergo a bone marrow aspirate and biopsy if this has not been recently performed. During this time, additional standard blood tests and/or radiology tests may be done to fully determine the extent of the cancer.
* Cell Collections: About 2-3 weeks before the infusion date, the donor will undergo one or two white blood cell collection procedures called leukopheresis. The cells collected from the first leukopheresis will be sent to the laboratory where a portion will be used to cultivate dendritic cells, and the remaining lymphocytes will be set aside for the DLI. If the number of cells collected at the first leukopheresis is insufficient, the donor will undergo a second leukopheresis procedure 7-10 days later.
* Infusions: We plan to administer the dendritic cells and donor lymphocytes separately in the outpatient clinic. The dendritic cells will be given first, followed by the DLI one to two days later.
* Follow-up after infusions: After completion of both the donor DC and DLI, participants will be followed closely for the development of side effects and response. They will be evaluated at least once a week, and routine blood tests and physical examination to assess for graft vs. host disease (GvHD) or other side effects will be performed. Additional blood tests will be done after 3, 6, and 10 weeks. At 10 weeks after the lymphocyte infusion, bone marrow aspirate and biopsy will be performed to assess the disease as well as the percentage of bone marrow cells that are derived from the donor. Additional restaging studies will also be performed at 10 weeks.

Donor Dendritic Cells And Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogeneic Transplant

Infusion of Donor Dendritic Cells and Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogenic Transplant

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

Principal Investigator

Antineoplastic Agents

Immunomodulating Agents

Chlorotrianisene

DC-TC+GM-CSF

Chengwei Chen

Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection and TACE Therapy will be evaluated.

The study is a single center,open label trial. To obtain safety information on toxicities and adverse events attributable to the subcutaneous injections of autologous dendritic cells incubated with irradiated autologous tumor stem cells and suspended in GM-CSF in patients with HCC.

Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

The number of adverse events along with the results of vital signs measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of DC-TC.

No.85 Hospital, Changning, Shanghai, China

China Cell Technology Ltd.

Cellular Biomedicine Group Ltd.

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Pharmaceutical Solutions

Antibodies

Antibodies, Monoclonal

Vaccines

Nivolumab

Immunoglobulins

Immunologic Factors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will receive nivolumab 3 mg/kg IV every 2 weeks for 8 weeks followed by surgery. Following resection, nivolumab and DC vaccine will be administered every 2 weeks (± 1) for a total of 3 vaccines, followed by biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.

Patients will initially receive the fourth cycle of nivolumab then receive nivolumab 3 mg/kg IV and DC vaccine every 2 weeks for a total of 3 vaccines, and then surgery. Subsequent to surgery, the patient will resume biweekly treatment with nivolumab and monthly DC vaccinations for a total of 5 more vaccines. Patients will continue to receive nivolumab every 2 weeks until progression.

Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes. Binding of PD-1 to its ligands, programmed death-ligands 1 and 2, results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T cell responses to both foreign antigens as well as self-antigens. Nivolumab is expressed in Chinese hamster ovary cells and is produced using standard mammalian cell cultivation and chromatographic purification technologies. The clinical study product is a sterile solution for parenteral administration.

nivolumab

DCs are potent immunostimulatory cells that continuously sample the antigenic environment of the host and specifically activate cluster of differentiation 4 positive (CD4+) and cluster of differentiation 8 positive (CD8+) T-cells and B-cells. They are at the crossroads of many of the elegant networks of the immune system, and DCs represent the most promising contemporary biologic entity for realizing the promise of immunotherapy. Potent immune responses and encouraging clinical results have been seen in Phase I and II human clinical trials in systemic cancers. Numerous animal studies and the investigator's institution's humans studies have demonstrated potent antitumor responses using DC-based immunotherapy against MGs.

Katherine Peters, MD, PhD

Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.

This two-arm randomized trial will evaluate the safety of nivolumab in combination with DC vaccinations for the treatment of bevacizumab-naïve subjects with first or second recurrent, resectable World Health Organization (WHO) Grade III and IV malignant gliomas (MGs). Up to 66 patients will be enrolled and treated with the goal of accruing 30 patients (15 per arm) that will receive nivolumab and at least 3 vaccines. After enrollment, leukapheresis will be done for generation of DC vaccines and immunologic monitoring. All subjects will undergo standard of care tetanus booster vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Subjects will initially return every 2 weeks and receive approximately 3 infusions of nivolumab 3 mg/kg IV while the DC vaccines are being prepared from the initial leukapheresis and will then be randomized 1:1 to one of 2 arms (Group I: nivolumab only pre-surgery; Group II: nivolumab with DC vaccines pre-surgery). Patients who are unable to tolerate nivolumab will be withdrawn from the study and replaced. Patients whose DCs or Peripheral Blood Lymphocytes (PBLs) fail to meet release criteria will continue to receive nivolumab only and will not undergo repeat leukapheresis. For patients whose leukapheresis yields less than 4 vaccines, a repeat leukapheresis may be obtained a minimum of 2 weeks from the previous leukapheresis (and may be repeated as needed) if stable. Peripheral blood will be drawn for immune monitoring prior to treatment with the 4th cycle of nivolumab (first post-randomization infusion of nivolumab).

Group I Treatment Plan (Nivolumab Only Pre-Surgery) After randomization, patients in Group I will receive nivolumab 3 mg/kg IV every 2 weeks x approximately 8 weeks. The subject will then undergo surgical resection of tumor within approximately 1-3 weeks. Approximately 2-4 weeks later, leukapheresis is repeated for generation of DC vaccines and immunologic monitoring. Approximately 1 day to 2 weeks after leukapheresis, the subject will resume nivolumab 3mg/kg IV every two weeks with DC vaccine administration intradermally (i.d.) for a total of 3 vaccines. At the time of the third DC vaccine, patients will receive vaccine site pre-conditioning. A single dose of Td toxoid (1 flocculation unit (Lf) in 0.4 milliliters (mL) of saline) will be administered to a single side of the groin i.d. (as described above for all vaccine administrations 12-24 hours prior to the third DC vaccine, which is always given bilaterally at the groin site. At the vaccine #3 visit, prior to vaccine # 3 administration, erythema and induration measurements will be taken of pre-conditioning site. Group I subjects will then receive monthly DC vaccine administrations intradermally for 5 months or until progression (whichever comes first).Total vaccines to be administered will be 8 post-surgery unless subject is removed. Nivolumab will continue until progression. At the clinic visit following the last vaccine (#8), subjects will have peripheral blood drawn for immune monitoring prior to infusion of nivolumab.

Group II Treatment Plan (Nivolumab with DC Vaccines Pre-Surgery) After randomization, patients in Group II will receive the fourth cycle of nivolumab then receive nivolumab 3 mg/kg IV along with DC vaccines intradermally every 2 weeks x approximately 6 weeks for a total of 3 vaccines. At the time of the third DC vaccine, patients will receive vaccine site pre-conditioning. A single dose of Td toxoid (1 Lf in 0.4 mL of saline) will be administered to a single side of the groin i.d. 12-24 hours before the third DC vaccine, which is always given bilaterally at the groin site. At the vaccine #3 visit, prior to vaccine #3 administration, erythema and induration measurements will be taken of pre-conditioning site.The subject will then undergo surgical resection of tumor within approximately 1-3 weeks. Approximately 2-4 weeks later, leukapheresis is repeated for generation of DC vaccines and immunologic monitoring. Approximately 1 day to 2 weeks after leukapheresis, the subject will resume nivolumab 3mg/kg IV every two weeks. When DC vaccines have completed processing and are available for administration, monthly DC vaccine administrations as described above will be administered for 5 months or until progression (whichever comes first). Total vaccines to be administered will be 8 (3 pre- and 5 post-surgery) unless subject is removed. Nivolumab will continue until progression. At the clinic visit following the last vaccine (#8), subjects will have peripheral blood drawn for immune monitoring prior to infusion of nivolumab.

Nivolumab With DC Vaccines for Recurrent Brain Tumors

AVeRT: Anti-PD-1 Monoclonal Antibody (Nivolumab) in Combination With DC Vaccines for the Treatment of Recurrent Grade III and Grade IV Brain Tumors

The percentage of patients who experience unacceptable toxicity during combination treatment by arm is tabulated. Unacceptable toxicity is defined as any grade 3, 4, or 5 adverse event that is possibly, probably, or definitely related to either nivolumab or DC vaccination treatment during concurrent treatment, or any Grade 2 drug-related uveitis or eye pain or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment. In addition, any complication following resection (ex. excessive intracranial bleeding, delays in wound healing) that are prolonged longer than 4-6 weeks post-surgery will be considered an unacceptable toxicity.

Survival is defined as the time between first initiation of nivolumab and death, or last follow-up if the patient remains alive. The Kaplan-Meier estimator will be used to describe the overall survival (OS) experience of all patients. Median OS is presented. Patients who are not able to tolerate nivolumab and are removed from the study will not be included in these analyses. Patients for whom DC vaccines cannot be manufactured will not be included in the survival analyses.

PFS is defined as the time between treatment initiation and initial progression or death, or date of last follow-up if the patient remains alive without disease progression. The Kaplan-Meier estimator will be used to describe the PFS experience of all patients. Median PFS is presented. Patients who are not able to tolerate nivolumab and are removed from the study will not be included in these analyses. Patients for whom DC vaccines cannot be manufactured will not be included in the survival analyses. Tumor assessment will be made using Response Assessment in Neuro-Oncology (RANO) criteria, which defines progressive disease as an increase by at least 25% in the sum of the products of perpendicular diameters from the baseline scan, a significant increase in T2/FLAIR non-enhancing lesions, or clinical decline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia	NCT00513123	Cervical Cancer	Colposcopy	18 Years -	M.D. Anderson Cancer Center
Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).	NCT02026362	Hepatocellular ...	MASCT:Multiple ... The foundation ...	20 Years - 70 Years	HRYZ Biotech Co.
Donor Dendritic Cells And Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogeneic Transplant	NCT00476177	Hematologic Mal...	Infusion of don... Infusion of don...	18 Years -	Dana-Farber Cancer Institute
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy	NCT01828762	Primary Hepatoc...	DC-TC+GM-CSF	18 Years - 80 Years	Cellular Biomedicine Group Ltd.
Nivolumab With DC Vaccines for Recurrent Brain Tumors	NCT02529072	Malignant Gliom... Astrocytoma Glioblastoma	nivolumab DC	18 Years - 80 Years	Duke University
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy	NCT01828762	Primary Hepatoc...	DC-TC+GM-CSF	18 Years - 80 Years	Cellular Biomedicine Group Ltd.

Spots Global Cancer Trial Database for dc

Every month we try and update this database with for dc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dc

Every month we try and update this database with for dc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.