L-ornithine L-aspartate (6 ampules, each ampule containing 5 grams of the drug in 10 ml solution) to be diluted in 440 ml of Dextrose 5% (to make a total of 500 ml of solution), as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo (sterile water, 6 ampuoles of 10 ml each) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Cirrhosis of Liver

Hepatic Encephalopathy

L-ornithine L-aspartate

Placebo (sterile water, 60 ml) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo

Department of Gastroenterology, D.M.C. and Hospital

G.B. Pant Hospital

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Efficacy of Intravenous 'L-ornithine L-aspartate' in Reversal of Overt Acute Hepatic Encephalopathy in Patients With Liver Cirrhosis: a Prospective, Randomized, Double-blind, Placebo Controlled Trial

Mental state grade according to West Haven criteria for Hepatic encephalopathy

Change in blood ammonia levels will be measured at baseline and after 5 days of treatment

Mortality rate in the two groups at 4 weeks will be compared

The total length of hospital stay (number of days) in each group will be compared.

Change in serum cytokine levels (Interleukin-1, Interleukin-6, Interleukin-10 and TNF-alpha will be measured at baseline and after 5 days of treatment.

Prof. Sandeep S Sidhu

Professor

Dayanand Medical College and Hospital

Doses of AUC 5-6 of carboplatin in combination with 75 mg/m2 of docetaxel are easily combined, being myelosuppression the most important toxicity. This combination has been studied in metastatic breast cancer as well as in the neoadjuvant setting. The combination of taxanes and platinum salts is increasingly used as neoadjuvant chemotherapy for TNBC. The docetaxel-carboplatin (TCb) regimen is an active and tolerable regimen in metastatic and locally advanced breast cancer, and the efficacy and toxicity characterization in the clinical setting are regaining interest in the era where the role of anthracyclines is controversial in the adjuvant setting. The avoidance of potentially serious long-term toxicities in specific breast cancer subtypes is a real challenge in an attempt to individualize therapies.

Breast Cancer

Breast Cancer Stage II-III

Docetaxel 75mg/m2 day 1 and Carboplatin(AUC6)day 1, each 21 days for 6 cycles.

Docetaxel- Carboplatin

Hospital Universitario Gregorio Marañon

Predictors of Response to Neoadjuvant Docetaxel-Carboplatin Chemotherapy for Patients With Stage II and III Triple Negative Breast Cancer

The primary objective of the study is to identify predictors of response to docetaxel-carboplatin in patients with triple negative primary tumors. Response is defined as lack of invasive tumor in breast plus axilla after neoadjuvant chemotherapy (PCR, pathological complete response).

To identify predictors of good pathological response according to Symmans criteria (i.e. Symmans class 0+1)
To identify predictors of chemoresistance (class III od Symmans)
To assess the clinical response rate by standard methods (MRI, clinical examination, mammogram) in patients treated with this regimen.
To evaluate breast conserving surgery rate in patients treated with this regimen.
To evaluate the pCR rate in patients with known BRCA mutations.

Miguel Martín Jiménez

Professor of Medicine, Medical Oncology Service

UNC Lineberger Comprehensive Cancer Center

Hospital Universitario Ramon y Cajal

Hospital San Carlos, Madrid

Centro Nacional de Investigaciones Oncologicas CARLOS III

Total skin electron beam therapy (TSEBT) will be performed per institution guidelines.
Vorinostat will be administered at a dose of 400 mg/day, starting one day prior to the initiation of TSEBT. During TSEBT, vorinostat should be taken in the morning and preferably prior to TSEBT.

Total skin electron beam therapy (TSEBT) will be administered according to the Stanford 6-field technique or equivalent technique per institutional standards. Patients will receive a planned total skin dose of 12 grey (Gy) fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. Supplements will routinely be applied to the perineum and soles as well as any other "shadowed" sites involved by disease, such as the inframammary regions (1-2 Gy fractions to a total dose of 12 Gy). Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy.

• TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.

TSEBT Only

TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.

TSEBT Plus Vorinostat

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Participants are stratified by MF stage as follows.
Stage IB: ~10 % skin involvement, with up to 1000/mm3 clone+ Sezary cells in blood. No abnormal lymph nodes.
Stage IIA: Up to 10% skin involvement, with up to 1000/mm3 clone+ Sezary cells in blood & clinically abnormal peripheral lymph nodes.
Stage IIB: One or more tumors 1 cm in diameter, with up to 1000/mm3 clone+ Sezary cells in blood & clinically abnormal peripheral lymph nodes.
Stage IIIB: Skin erythema >80 % body surface area, with up to 1000/mm3 clone+ Sezary cells in blood & clinically abnormal peripheral lymph nodes.

Clinical Stage

Complete Clinical Response (CCR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0. mSWAT is an objective, quantitative, severity-weighted method to assess the extent of mycosis fungoides (MF) lesions, and is determined by total body surface area (%TBSA) of the lesion by a severity-weighting factor (1 = patch; 2 = plaque; 4 = tumor). O% TBSA produces a product of 0, indicating complete response.

Complete Clinical Response (CCR)

Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm.

Safety and Tolerability as Measured by Severity and Frequency of Adverse Events

Clinical Response Rate (CRR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0, consisting of complete response (CR) rate; partial response (PR) rate; stable disease (SD) rate; or progressive disease (PD) rate.
CR = 100% clearance of skin disease (mSWAT score = 0) PR = 50%to <100% clearance of skin disease as measured by > 50% decrease of mSWAT score compared with baseline SD = Not CR, PR, or PD
PD = Whichever is met first of:
> 25% increase in skin disease from baseline as measured by > 25% increase of mSWAT score compared with baseline
New tumor (T3) lesions in patients without prior T3 lesions (T1, T2, T4) or
In responders (confirmed), increase in skin disease over nadir by 50% of baseline as measured by mSWAT score of > [nadir + > 50% of baseline]
Relapse applies to any new disease after confirmed CR

Clinical Response Rate (CRR)

Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment until progressive disease, as measured by the mSWAT skin assessment, and censored at the final per-protocol assessment (48 weeks)

Duration of Clinical Benefit (Per Protocol Follow-up)

Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment or until progressive disease, as measured by the mSWAT skin assessment.

Duration of Clinical Benefit (Supplemental Follow-up)

TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
Vorinostat 400 mg/day continuing for 8 weeks total.

Overall Study

Youn H Kim, MD

TSEBT (12Gy) per institutional guidelines.

TSEBT (12Gy) per institutional guidelines.
Vorinostat 400 mg daily starting one day prior to the initiation of TSEBT.

TSEBT & Vorinostat

Cutaneous Lymphoma

Cutaneous T-cell Lymphoma

TSEBT is administered as 12 Gy fractionated at 2 grey (Gy)/cycle (each cycle requiring 2 days of treatment); 4 days each week; for 3 weeks.

Total skin electron beam therapy (TSEBT)

Starting doses of is vorinostat 400 mg/day, continuing for 8 weeks.

Vorinostat

Stanford University School of Medicine

Yale University School of Medicine

MD Anderson Cancer Center

Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides

A Multicenter, Open-label, Randomized, Phase I/II Study Evaluating the Safety and Efficacy of Low-dose (12 Gy) Total Skin Electron Beam Therapy (TSEBT) Combined With Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides (MF)

hypokalemia/fatigue

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Predictors of Response to Neoadjuvant Docetaxel-Carboplatin Chemotherapy for Patients With Stage II and III Triple Negative Breast Cancer

Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides

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