Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Immunoblastic Lymphadenopathy

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Lymphadenopathy

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Angioimmunoblastic T-cell Lymphoma

Angioimmunoblastic Lymphadenopathy With Dysproteinemia

Lymphoma, Large-cell, Immunoblastic

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine

Doxorubicine

Corinne Haioun, MD

Bertrand Joly, MD

To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).

The duration of the treatment period is approximately 25 weeks and patients are followed until Death.

The total Duration of the study is expected to be 2.5 years.

A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).

\[Complete response (CR), Complete response unconfirmed (CRu)\] after the end of treatment.

Hoffmann-La Roche

Lymphoma Study Association

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Pancreatic Neoplasms

Pleural Effusion

Stomach Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ascites

Pleural Diseases

Mesothelioma

Mesothelioma, Malignant

Peritoneal Neoplasms

Pseudomyxoma Peritonei

Gallbladder Neoplasms

Appendiceal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms, Mesothelial

Respiratory Tract Diseases

Pancreatic Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Adenocarcinoma

Adenocarcinoma, Mucinous

Carcinoma

Neoplasms, Cystic, Mucinous, and Serous

Cecal Neoplasms

Cecal Diseases

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Gallbladder Cancer

Malignant Mesothelioma

Pharmaceutical Solutions

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Cisplatin

Mitomycins

Mitomycin

A chemotherapeutic solution is aerosolized into the expanded abdominal cavity during laparoscopy, under pressure. This allows a relatively homogeneous repartition of the drug and an effective tissue penetration.

PIPAC

Sabine Rhode

Laura Lay, MD

Craig Lynch, MD

Tarkan Jäger, MD

Woulter Willaert, MD

Martin Graversen, MD

Catherine Arvieux, MD

Clarisse Eveno

Olivier Glehen, MD

Olivia Sgarbura, MD

Verena Schlaich

Marco Vaira, MD

Maciej Nowacki, MD

Vladimir Khomyakov, MD

Janelle Phua

Juan Torrent, MD

Martin Huebner, MD

Philipp Horvath, MD

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

All data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to identify potential prognostic and predictive factors. In particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned.

The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The registry has received approval of the data protection officer of the State of Northrhine-Westphalia.

The study steering committee is blinded towards the identity of the participating institutions. Each participating institution receives an annual report with own data vs. benchmark. Scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board.

An export function has been built in to allow data exchange with the HIPEC Registry of the German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).

International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany

according to RECIST criteria (CR + PR + SD)

according to the Peritoneal Regression Grading Score (PRGS)

Ruhr University of Bochum

Coordinator

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Doxorubicine pegylated

Mathilde HUNAULT BERGER, RN

Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone

Patients aged 55 years or over will be assessed for response to steroids from day -7 to day 0 During steroid therapy, Ph status will be determinated : patients with Ph+ ve ALL will be treated according to the another French Protocol while patients with Ph-ve ALL will be included in the "caelyx" protocol and randomly allocated to induction with VAD or with vadox-li-Peg (caelyx).

A second course of induction therapy with VAD+ cyclophosphamide of Vadox-li-peg+ cyclophosphamide(according to the initial randomization arm) will then be given to all patients.

Consolidation therapy included 2 courses of vad or of vadox-li-Peg , according to the initial random allocation, followed by two courses of cytarabine,cyclophosphamide and thioguanine.

During induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin pharmacokinetics will be assessed in all patients.

Treatment of occult CNS invasion includes skull radiotherapy and 6 intrathecal injections(steroÏds+methotrexate) A two years maintenance course with 6 mercaptopurine and methotrexate will then be offered to all patients.

Liposomal Anthracyclin in the Treatment of Elderly ALL

A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients

French Innovative Leukemia Organisation

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Immunomodulating Agents

Transfer of autologous dendritic cells interspersed with chemotherapy doses

Control patients who follow their basic treatment with chemotherapy with the A/C scheme

Dendritic cells

Fabio Méndez, MD

This study aims to evaluate for the first time in Colombia the immunogenicity and safety of autologous DCs as enhancers of the immune response in patients with ductal breast cancer who, prior to surgical resection of the tumor, will receive neo-adjuvant chemotherapy with Doxorubicin and Cyclophosphamide. concomitantly with the transfer of autologous DCs. This clinical trial is based on the concept proposed in countries like France more than a decade ago, that chemotherapy or radiotherapy cause the tumor cells to release certain signals that favor the activation of the immune system against cancer. Therefore, the combined use of chemotherapy with vaccination with dendritic cells would provide the immune system with greater antitumor response capacity, taking advantage of the release of said signals to initiate a series of processes that would be reflected in the activation of T lymphocytes capable of destroying the remaining cells of the tumor. To determine the specificity of the response evoked by the adoptive transfer of autologous DCs, in each patient the degree of recognition of the tumor by the immune system before and after said procedure will be evaluated. These results will be compared with those of patients who participated in a control group.

Hypothesis Adoptive transfer of autologous DCs generated in vitro, in patients with stage IIA-IV breast cancer who receive neoadjuvant therapy with Doxorubicin and Cyclophosphamide, is a safe procedure that stimulates anti-tumor immune responses in treated patients.

Principal aim:

To evaluate the safety and immunogenicity of the use of DCs when used in patients with stage IIA-IV breast cancer in association with neo-adjuvant chemotherapy with Doxorubicin/Cyclophosphamide.

Specific aims:

* Generate immuno-competent dendritic cells in conditions of Good Clinical Practice and Good Laboratory Practices.
* Determine in each patient the immunological status of specific T lymphocytes against tumor antigens, before and after chemotherapy, in order to demonstrate whether the adoptive transfer of DCs favors the anti-tumor immune response.
* Register in patients with breast cancer in neo-adjuvant chemotherapy the class and frequency of adverse effects that could be generated as a result of the adoptive transfer of autologous DCs.

The Fundación Salud de los Andes in the framework of a strategic alliance with the National University of Colombia has been working in the planning and development of a clinical trial in Colombia that promotes the search for new therapeutic alternatives for cancer patients. As a translational medicine project, it aims to make the laboratory findings available to the patient. This study explores the combination of immunotherapy (cell therapy) with chemotherapy, in order to obtain better results in the therapeutic management of tumors in patients with breast cancer.

Problem:

Breast cancer is a pathology that in recent years has increased vertiginously its incidence globally. Given the advanced state in which this tumor is usually diagnosed in our environment, the prognosis is seriously compromised, which has led to the current breast cancer represents a major public health problem in Colombia. The established therapies for the management of patients with this type of tumors such as chemotherapy, radio-therapy or surgery, are effective to reduce much of the established tumor mass, but fail to eliminate residual cancer cells, so - often - these treatments cannot prevent the recurrence of the disease. In addition to the above, the quality of life of the patients treated is strongly affected by the toxicity of these treatments on healthy tissues and their undesirable effects, which frequently affects poor adherence to treatment. That is why it is necessary to search for new therapeutic alternatives that are more specific to the tumor and that are better tolerated by patients. Due to the high specificity of the immune system for the recognition of tumors, different modalities of immune therapy for tumor control are currently being explored, which seek to enhance the performance of the patient's defense system so that a cytotoxic and memory response is established against them. tumor cells.

Type of study Clinical Trial Phase I / II.

Methodology:

Patients who attend the consultation due to their mammary pathology for the start of neo-adjuvant chemotherapy will be pre-selected to participate in the study. The participation of the volunteers will be subject to compliance with the inclusion and exclusion criteria defined for the study, as well as the signing of the informed consent. The participants will be randomly distributed into two groups.

PATIENT GROUPS As part of the clinical evaluation at the entrance of the study, a battery of laboratory tests (basic and specific to the trial) will be carried out. Subsequent to the corroboration of compliance with the inclusion criteria, patients will be randomly assigned to one of the two study groups: The first group (A) will be the negative control group, which includes patients who will receive only the standardized chemotherapy treatment for the pathology. The second group (B) will consist of those patients who were randomly selected to receive the adoptive transfer of mature autologous DCs in combination with the neo-adjuvant chemotherapy. In this way, the total of 30 patients will be distributed as follows: 15 patients for group A and 15 patients for group B.

The patients of group B will undergo an apheresis procedure in order to obtain a sample enriched in peripheral blood monocytes from which monocytes will be purified for the production of DCs. The generation of DCs will be carried out under strict conditions of Good Clinical Practices and Good Laboratory Practices.

The adoptive transfer will be carried out concomitantly with the neo-adjuvant chemotherapy treatment (eight and 15 days after chemotherapy dose for a total of 6 injections with autologous DCs).

In the period of application of the doses, a permanent clinical evaluation will be carried out to the patients, to register possible adverse effects (evaluation of the safety of the adoptive transfer of autologous DCs). The effect on the immune response of autologous DCs transferred to patients on chemotherapy vs. the effect on the immune response of chemotherapy without transfer, will be analyzed in each patient before and after chemotherapy using the state of the art of immunological techniques with which will measure the extent of anti-tumor CD8+ T cells expansion (evaluation of the immunogenicity of the adoptive transfer of autologous DCs).

Participating Institutions:

Fundación Salud de los Andes Research Group in Immunology and Clinical Oncology - GIIOC

National University of Colombia - Bogotá. School of Medicine Immunology and Translational Medicine Group Departments of Microbiology and Pathology

Other collaborating institutions:

Clínica del Seno Hospital Universitario Nacional Instituto Nacional de Cancerología Oncocare

Immunogenicity and Safety of DCs in Breast Cancer

Immunogenicity and Safety of Autologous Dendritic Cells in Patients With Breast Cancer Treated With Neoadjuvant Chemotherapy.

Number of participants with treatment-related adverse events as associated with DCs inoculation assessed by CTCAE v4.0

Universidad Nacional de Colombia

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Fundación Salud de los Andes

Hodgkin Disease

Hodgkin Lymphoma

Lenalidomide

Vinblastine

Angiogenesis Inhibitors

Growth Inhibitors

Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results

DTIC

Andreas Engert, Prof.

The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.

Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients

Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients

University of Cologne

Prof.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma	NCT00169156	Untreated T-cel...	Rituximab Prednisone Doxorubicine Cyclophosphamid... Vincristine	18 Years - 75 Years	Lymphoma Study Association
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)	NCT03210298	Peritoneum Canc... Peritoneum Neop... Pleural Cancer Pleural Effusio... Pleural Mesothe... Ovarian Cancer Gastric Cancer Appendix Cancer Pseudomyxoma Pe... Colorectal Canc... Pancreas Cancer Gallbladder Can... Ascites CUP Chemotherapeuti...	PIPAC	10 Years -	University of Magdeburg
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)	NCT03210298	Peritoneum Canc... Peritoneum Neop... Pleural Cancer Pleural Effusio... Pleural Mesothe... Ovarian Cancer Gastric Cancer Appendix Cancer Pseudomyxoma Pe... Colorectal Canc... Pancreas Cancer Gallbladder Can... Ascites CUP Chemotherapeuti...	PIPAC	10 Years -	University of Magdeburg
Liposomal Anthracyclin in the Treatment of Elderly ALL	NCT00600977	Acute Lymphobla...	Doxorubicine Doxorubicine pe...	55 Years -	French Innovative Leukemia Organisation
Immunogenicity and Safety of DCs in Breast Cancer	NCT03450044	Breast Cancer F...	Dendritic cells	30 Years - 65 Years	Fundación Salud de los Andes
Immunogenicity and Safety of DCs in Breast Cancer	NCT03450044	Breast Cancer F...	Dendritic cells	30 Years - 65 Years	Fundación Salud de los Andes
Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients	NCT01056679	Hodgkin Lymphom...	Doxorubicine DTIC Lenalidomide Vinblastine	60 Years - 75 Years	University of Cologne

Spots Global Cancer Trial Database for doxorubicine

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