Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Kidney Diseases

Adenocarcinoma

Carcinoma, Renal Cell

Urologic Neoplasms

Urologic Diseases

Urogenital Neoplasms

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Coagulants

Angiogenesis Inhibitors

Adjuvants, Immunologic

Platelet Factor 4

Patients having a radical or partial nephrectomy.

Patients treated by RCC-directed targeted therapy

2 blood samples of 10mL + one urine sample

* on pre-operative d-1/d, post-operative d1 and d5(+/-2),
* one month post-operative,
* at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises.

Biological sample

2 blood samples of 10mL + one urine sample

* before starting the therapy
* at first therapeutic evaluation (2 or 3 months depending on the treatment chosen)
* at the end of the study or at the date of disease progression.

Jean-Christophe BERNHARD, Dr

Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.

The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management.

Therefore the identification of new molecular biomarkers is important:

* to improve the precision of prognostic models currently based on clinical, biological or histopathological variables
* to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up
* to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia
* to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification

Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.

Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence.

Localized or locally advanced renal cell carcinoma group:

* local recurrence
* contralateral recurrence
* extra-renal distant recurrence (metastatic progression)
* specific cancer death
* nonspecific cancer death

Metastatic renal cell carcinoma group :

* local recurrence for patients who underwent a nephrectomy
* contralateral reccurence
* metastatic progression
* specific cancer death
* nonspecific cancer death

Predictive value of therapeutic response will be assessed for patients receiving systemic therapy. It will be evaluated by the association of markers of interest with the therapeutic response.

* RECIST criteria: patients showing a complete response or a partial response, will be considered as "responders"
* The progression of the longest diameter of tumor, the proportion of intra-tumor necrosis (Choi criteria) and +/- the perfusion characteristics of tumor if primitive tumor

University Hospital, Bordeaux

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Interferons

Interferon-alpha

Peginterferon alfa-2a

Interferon alpha-2

Antiviral Agents

Immunologic Factors

pegylated interferon-alpha-2a

interferon-alpha-2a

Claus Garbe, MD

Hubert Pehamberger, MD

The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.

A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.

Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-alpha-2 (PEG-IFN) to 'Low-dose' Interferon-alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002)

Dermatologic Cooperative Oncology Group

University Hospital Tuebingen

Blood and Lymph Conditions

Immune System Diseases

Urinary Bladder Neoplasms

Lymphoproliferative Disorders

Urinary Bladder Diseases

MAGE-A3 positive patients treated with recMAGE-A3 + AS15 ASCI

MAGE-A3 positive patients treated with placebo

5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months

recMAGE-A3 + AS15 ASCI

Placebo

Peter FA Mulders, Prof,PhD,MD

The purpose of this clinical trial was to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections was administered over 27 months.

This study assessed an investigational treatment for patients with Muscle Invasive Bladder Cancer in whom the urinary bladder had been surgically removed. The investigational treatment aimed to increase the body's immune response to a specific antigen expressed by the cancer. The tumour tissue was first tested whether it expressed the MAGE-A3 antigen.

The MAGNOLIA study was open to male and female patients with pathologically confirmed muscle invasive transitional cell carcinoma of the urinary bladder with expression of the antigen MAGE-A3 with or without limited lymph node involvement who had no evidence of disease after surgery confirmed with imaging procedures (scans CT/MRI).

Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy

A Randomized, Double Blind, Placebo Controlled Phase II Trial to Evaluate the Safety and Efficacy of recMAGE-A3 + AS15 ASCI in Patients With MAGE-A3 Positive Muscle Invasive Bladder Cancer After Cystectomy

To evaluate of the clinical efficacy in terms of Disease Free Survival of treatment versus placebo in the overall population of patients with bladder cancer with MAGE-A3 expression after cystectomy. Disease Free Survival is the time from randomization to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurred first. Types of recurrence considered as an event included loco-regional and distant metastases. In addition, any death occurring without prior documentation of tumor recurrence was considered as an event (and was not censored in the statistical analysis) as this approach is less prone to introduce bias.

To evaluate overall survival in the overall study population. Overall Survival was defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive were censored at the date of the last assessment.

To evaluate Disease-free specific survival in the overall population.Disease-free specific survival was defined as the interval from randomization to the date of first recurrence of disease or date of death due to bladder carcinoma, whichever occurred first. Patients without recurrence or death were censored at the date of last assessment. Patients without recurrence who died from another cause were censored at the date of death.

To evaluate Distant metastasis-free survival in the overall study population. Distant metastasis-free survival was defined as the interval from randomization to the date of first distant metastasis or date of death, whichever occurred first. Patients alive and without distant metastasis were censored at the date of last assessment.

GlaxoSmithKline

European Association of Urology Research Foundation

It was pre-specified in the Protocol that Foreseeable AEs and SAEs specifically related to the cystectomy prior to first study treatment administration will not be considered as "Adverse Events". It was left to the investigator to asses the relation between the (S)AEs and the cystectomy. Progression/recurrence of the tumor were recorded in the clinical assessments in the eCRF and not as SAE.

Death due to a progressive disease were recorded on a specific form in the eCRF but not as a SAE.

MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI

recMAGE-A3 + AS15 ASCI: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months

recMage-A3 + AS15 ASCI

Placebo: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Netherlands

Czechia

Poland

Italy

France

Germany

Russia

Spain

Region of Enrollment

T2 (tumor invades muscle), T3 (tumor invades perivesical tissue), T4 (tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall).

T-category of bladder cancer at diagnosis

N0: No regional lymph node metastasis N1: Metastasis in a single lymph node 2 cm or less in greatest dimension N2: Metastasis in n a single lymph node more than 2 cm but not more than 5 cm in greatest dimension, or multiple lymph nodes, none more than 5 cm in greatest dimension.

N-category classification of bladder cancer at diagnosis

M0: No distant metastasis M1: Distant metastasis

M-category of bladder cancer at diagnosis

Dominant Histological Type

Mean weight

Mean Height

The Total Treated population included all treated patients, i.e. all patients with at least one documented dose of study treatment (ASCI or placebo).

Trial's recruitment was prematurely stopped. The recMAGE-A3+ AS15 patients were given the opportunity to continue treatment whereas placebo patients needed to stop treatment. All clinical data collected in this study were analysed descriptively.

Wim P.J. Witjes, MD, PhD Scientific and Clinical Research Director

Disease Free Survival

Overall Survival

Disease-free Specific Survival

Distant Metastasis-free Survival

Overall Study

Natriuretic Agents

Antibodies

Vaccines

Ipilimumab

Mannitol

Immunoglobulins

Monatide (IMS 3015)

Freund's Adjuvant

Interleukin-12

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine

Jeffrey S. Weber, M.D., Ph.D.

This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.

In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.

Novel Adjuvants for Peptide-Based Melanoma Vaccines

An Open Label Study of MDX-CTLA4 in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB	NCT00204529	Melanoma	pegylated inter... interferon-alph...	18 Years - 75 Years	University Hospital Tuebingen
Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy	NCT01435356	Urinary Bladder...	recMAGE-A3 + AS... Placebo	18 Years -	European Association of Urology Research Foundation
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB	NCT00204529	Melanoma	pegylated inter... interferon-alph...	18 Years - 75 Years	University Hospital Tuebingen
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Novel Adjuvants for Peptide-Based Melanoma Vaccines	NCT00028431	Melanoma	MDX-CTLA4 Antib...	18 Years -	University of Southern California

Spots Global Cancer Trial Database for adjuvants, immunologic