Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Micronutrients

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Hematinics

Vitamins

Etoposide

Cytarabine

Leucovorin

Levoleucovorin

Methotrexate

Ifosfamide

Lenograstim

Folic Acid

Etoposide phosphate

Ofatumumab

Isophosphamide mustard

Mesna

Antimetabolites

Enzyme Inhibitors

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Antidotes

Protective Agents

Trace Elements

Adjuvants, Immunologic

Folinic Acid

Folate

Vitamin B9

Ofatumumab Etoposide Ifosfamide Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Colony Stimulating Factor

1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles

60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles

1500mg/m2 or 1000mg/m2 (patients \>/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles

Ifosfamid

300mg/m2 or 200mg/m2 (patients \>/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients \>/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles

2g/m2 or 0,5-1g/m2 (patients \>/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles

12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles

Leukovorin

5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC\>1.0x109/l

Granulocyte-Colony Stimulating Factor

Jan Walewski, Prof.

Krzysztof Warzocha, Prof.

Andrzej Hellmann, Prof.

Andrzej Pluta, Prof.

Andrzej Lange, Prof.

Wanda Knopinska-Posluszny, MD PhD

Sebastian Giebel, Prof.

Jan M Zaucha, Prof.

It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC) regimen. This study is planned to determine the efficacy and safety of ofatumumab in combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous Stem Cell Transplant (ASCT).

The purpose of this study is to assess the Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR) in adult Diffuse Large B Cell Lymphoma (DLBCL) patients progressing or relapsed after prior R-CHOP treatment not suitable for ASCT treated with O-IVAC salvage chemotherapy regimen. The secondary objective is the evaluation of progression-free survival (PFS), event-free survival (EFS), overall survival (OS), safety and tolerability.

Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

A Phase II Trial on Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients Progressing or Relapsed After Prior R-CHOP Treatment Not Suitable for Autologous Stem Cell Transplant

Staying free of event such as disease progression, relapse, death, starting new anticancer therapy, patient's refusal to continue study treatment, Serious Adverse Event that causes discontinuation of study treatment

Time since entering the study till death of any reason

Reporting Adverse Events and Serious Adverse Events

Polish Lymphoma Research Group

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Intravenous infusion of Calciumfolinat 60 mg/m²given to patients with colon cancer at the time for the operation of the colon cancer.

Intravenous infusion of Calciumfolinat 200 mg/m² given to patients with colon cancer at the time for the operation of the colon cancer.

Intravenous infusion of Calciumfolinat 500 mg/ m² given to patients with colon cancer at the time for the operation of the colon cancer.

Elinor Bexe Lindskog, MD, PhD

This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from patients with colon cancer

Cytotoxic treatment of patients with colorectal cancer (CRC) includes most various different drugs but 5-fluorouracil (5-FU) is the cornerstone in most regimens. Leucovorin (LV) is frequently used as a part of a standard treatment regime for advanced CRC in combination with 5-FU. In numerous randomized clinical trials the addition of LV to 5-FU has been shown to significantly improve the antitumor activity and to prolong the survival of patients receiving adjuvant chemotherapy or treatment for advanced disease as to compared to treatment with 5-FU as single drug therapy.

In most European countries 5-FU is given as an infusion during 46 hours in combination with a two hour infusion of LV. This regime is called the deGramont schedule. In the Nordic countries, 5-FU and LV are often given as bolus injections according to the regime called Nordic FLV. Leucovorin is a prodrug which has to be metabolized to methylenetetrahydrofolate (mTHF) in order to increase inhibition of the target enzyme thymidylate synthase (TS). Due to the low concentrations of the reduced folate forms intracellular there is a lack of knowledge of the pharmacodynamics of LV when used as an infusion. When the 5-FU/LV used today was introduced it was technically not possible to measure the different metabolites of the reduced folates in blood and tissue. In the literature there is only one published reference measuring the blood concentration after a two hour infusion of LV. However, it has recently been possible to separate and quantitate the different folates using sensitive Liquid Chromatography/Masspectrometry (LC/MS) methods. Furthermore it has been stated that differences in enzyme activity for genes involved in the transport and metabolism of folates may be responsible for the large inter individual differences in folate tissue concentrations.

This study is designed to gain an understanding of how a single intravenous infusion of LV affects the folate concentration in blood, tumor and adjacent mucosa tissue. By using the LC/MS method which was recently developed and it is now possible to quantitate the different metabolites of LV in small tissue samples as well as in blood. It is further now possible to measure by quantitative Polymerase Chain Reaction techniques (PCR) the most important genes involved in the folate transport and metabolism ((SHMT1), SerineHydroxyMethylTransferase1 and (ABCC3) ATP-binding cassette, sub-family C, (CFTR/MRP), member 3)).

PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer

An Open Randomized Single Site Pharmacokinetic and Pharmacodynamic Study, of Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in Blood, Tumor and Adjacent Mucosa From Patients With Colon Cancer

Tissue concentration of \[6R\] 5,10-methylene-THF in the tumor

Tissue concentration of \[6R\] 5,10-methylene-THF in adjacent mucosa

Tissue concentration of 5-formyl-THF in the tumor

Tissue concentration of 5-formyl-THFin the adjacent mucosa

Tissue concentration of 5-methyl-THF in the tumor

Tissue concentration of 5-methyl-THF in the adjacent mucosa

Tissue concentration of THF in the adjacent mucosa

AUC(0-24h) calculated from plasma concentration of \[6R\] 5,10-methylene-THF

AUC(0-24h) calculated from plasma concentration of 5-formyl-THF (if data

AUC(0-24h) calculated from plasma concentration of 5-methyl-THF (if data permits)

AUC(0-24h) calculated from plasma concentration of THF (if data permits)

Correlation between AUC calculated from blood concentration and tissue concentration in the tumor and adjacent mucosa

Gene expression in the tumor and correlation to tissue concentration of the reduced folates

Gene expression in the adjacent mucosa and correlation to tissue concentration of the reduced folates

Vastra Gotaland Region

Rectal Diseases

Irinotecan

Cetuximab

Fluorouracil

Oxaliplatin

Topoisomerase I Inhibitors

Antineoplastic Agents, Immunological

Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1

Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3

Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV

5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3

5-FLUOROURACIL

Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

John Souglakos, MD

This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab

Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer

A Triplet Combination With Irinotecan Plus Oxaliplatin,Continuous Infusion 5-Fluorouracil And Leucovorin Plus Cetuximab As First Line Treatment In Metastatic Colorectal Cancer. A Pilot Phase II Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients	NCT01481272	Diffuse Large B...	Ofatumumab Etoposide Ifosfamid Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Col...	18 Years -	Polish Lymphoma Research Group
Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients	NCT01481272	Diffuse Large B...	Ofatumumab Etoposide Ifosfamid Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Col...	18 Years -	Polish Lymphoma Research Group
PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer	NCT02959541	Colon Cancer Chemotherapy	Leucovorin	18 Years -	Vastra Gotaland Region
PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer	NCT02959541	Colon Cancer Chemotherapy	Leucovorin	18 Years -	Vastra Gotaland Region
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer	NCT00689624	Metastatic Colo...	Irinotecan Leukovorin Oxaliplatin 5-FLUOROURACIL Cetuximab	18 Years - 70 Years	University Hospital of Crete
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer	NCT00689624	Metastatic Colo...	Irinotecan Leukovorin Oxaliplatin 5-FLUOROURACIL Cetuximab	18 Years - 70 Years	University Hospital of Crete

Spots Global Cancer Trial Database for leukovorin

Every month we try and update this database with for leukovorin 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 leukovorin

Every month we try and update this database with for leukovorin 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 leukovorin 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.