NEWS HIGHLIGHTS
Clinical Trials Related to Soma Compound with Codeine (Carisoprodol / Aspirin / Codeine)
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer [Recruiting]
The purpose of this study is to evaluate the interest of breath holding for the prevention
of radiation pneumonitis following conformal radiation therapy.
Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath
holding during conformal radiation.
The primary objective of the study is to establish the efficacy of breath holding, compared
to free breathing, in the prevention of early pulmonary toxicity following conformal
radiation.
Several departments of radiotherapy, many pneumology units and two basic and applied
research laboratories take part in this multicentric study.
The number of patients required to demonstrate a reduction in radiation pneumonitis from 45
% to 22. 5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per
arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion
period should be approximately 3 years.
Interleukin-2 Treatment for Wiskott-Aldrich Syndrome [Recruiting]
Context: Wiskott-Aldrich syndrome (WAS) is a fatal, devastating disease with ill-defined
treatment modalities, which affects young boys. Classic WAS is characterized by a clinical
triad of thrombocytopenia, eczema and severe, recurrent infections. Despite diagnostic and
therapeutic advances most WAS patients die at less than 12 years of age due to infections,
hemorrhage, malignancy or complications from treatments. WAS patients suffer from
herpesvirus infections as a result of poor Natural Killer (NK) cell function (cytotoxicity).
In the laboratory, the investigators have seen correction of WAS Natural Killer Cell (NK)
function after treatment with Interleukin-2 (IL-2).
Objectives: Initiate a prospective clinical trial by treating WAS subjects with IL-2 and
using safety as the primary endpoint. Restoration of NK cell cytotoxicity and effects on
cytoskeletal dynamics are secondary endpoints. The investigators will also observe patient
clinical status (eczema, infections, use of treatment dose antibiotics, food allergies,
etc).
Study Design/Setting/Participants: This is a prospective clinical trial treating 9 WAS
subjects in the Clinical Translational Research Center (CTRC) with IL-2.
Intervention: The investigators propose to subcutaneously administer 0. 5 MU/m2 of IL-2 daily
to WAS subjects for 5 days. Research treatment will be repeated 2 and 4 months later.
Inter-patient dose escalation will be employed to 1 MU/m2 and/or 2 MU/m2 based on safety as
the primary endpoint.
Study Measures: The investigators will observe safety and tolerability measures and perform
assays on subject blood samples prior to and after research treatment to observe improvement
in NK cell function.
Trial of Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy [Recruiting]
Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve
complication of radiotherapy, that is spontaneously irreversible with no medical treatment
to limit or reduce symptoms. The investigators planed in RIP a randomized double blind
clinical trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus
placebo, to assess a possible symptomatic regression by a sensory-motor neurological
quantifiable and reproducible score (modified Subjective Objective Medical management
Analytic, SOMA).
The investigators previously developed a successful PE treatment in symptomatic RI injuries
via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a
major significant radiation-induced fibrosis regression, then the PE clodronate combination
(PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and
significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50
partial RIP.
The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its
tolerance in long survival patients irradiated before for cancer and presenting with partial
RIP of upper or lower legs.
The investigators calculated to include 60 patients to show a significant clinical
difference between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400
(2x/d) + vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple
placebo, with prednisone 20 (2d/7) for all patients.
RIP is assessed before treatment and every 6 months by a standardized sensory-motor
neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and
various neurological scales of assessment (Visual Analog Scale for pain / VAS for
paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS],
muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient
Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and
electrophysiology.
A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses [Recruiting]
An individual's genetic make-up is known to determine their response to antipsychotic
medication. Genetic markers that determine efficacy and side effects of medication may be
identified and used to predict treatment outcome.
The study is a naturalistic study of routinely prescribed antipsychotics using outcome
measures undertaken as part of the routine clinical care of the cohort. These clinical data
are linked with genetic information obtained from DNA and RNA from blood samples undertaken
as part of the study.
No alteration is made to the subjects treatment regime or medication.
The study is a two stage investigation:
- The first stage involves the collection of a databank of clinical information and blood
samples for DNA and RNA extraction from patients treated with antipsychotic medication.
- The second stage is a molecular genetic investigation of treatment-related genetic
factors that may contribute to response prediction and predisposition to side effects.
From these genetic studies pharmacogenetic prediction tests will be validated and/or
developed.
Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries [Recruiting]
The principle objective of this research is to more precisely determine the degree of
benefit that hyperbaric oxygen therapy affords in the treatment of late radiation tissue
injury.
The study has eight* components. Seven involve the evaluation of established radionecrosis
at varying anatomic sites (mandible, larynx, skin, bladder, rectum, colon, and gyn). The
eighth will investigate the potential of hyperbaric oxygen (HBO) therapy to prophylax
against late radiation tissue injury.
*(One of the arms, HORTIS IV - Proctitis has been closed to further patient recruitment.
This decision was based on an interim statistical analysis which generated sufficient
evidence to support closing down this arm of HORTIS.)
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