Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Adenocarcinoma

Stomach Neoplasms

Nausea

Vomiting

Pain

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Signs and Symptoms, Digestive

Esophageal Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

docetaxel

steroid therapy

questionnaire administration

nausea and vomiting therapy

pain therapy

quality-of-life assessment

standard follow-up care

radiation therapy

Hugo Ford, MD

RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping to control symptoms caused by cancer. It is not yet known whether these treatments are more effective when given with or without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.

PURPOSE: This randomized phase II trial is studying symptom control given together with docetaxel to see how well it works compared with symptom control given without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.

OBJECTIVES:

Primary

* To compare overall survival of patients with relapsed adenocarcinoma of the esophagus or stomach after treatment with docetaxel and active symptom control vs active symptom control alone.

Secondary

* To determine the time to documented progression in patients treated with docetaxel.
* To assess response rates to docetaxel in patients treated with docetaxel.
* To determine toxicity of docetaxel in patients treated with docetaxel.
* To assess the quality of life of these patients.
* To evaluate the health economic impact.

OUTLINE: This is a multicenter study.

Patients are stratified according to stage (locally advanced vs metastatic), site of disease (esophagus vs esophagogastric junction vs stomach), duration of response to prior chemotherapy (no response vs response duration \< 3 months vs response duration 3-6 months), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive docetaxel IV over 1 hour on day 1 and active symptom control (e.g., analgesics \[including opioids\], antiemetics, steroids, palliative radiotherapy) daily.
* Arm II: Patients receive active symptom control as in arm I. Courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients in arm I undergo tissue biopsy collection at baseline and after 3 courses of treatment for biomarker analysis.

Quality of life is assessed by the QLQ-C30 and QLQ-STO22 questionnaires at baseline and at 3, 6, 9, 12, 18, and 24 weeks. Health resource use is assessed by the EQ-5D questionnaire at baseline and then periodically during and after treatment.

After completion of study treatment, patients are followed up every 6 weeks for 1 year and then every 3 months thereafter.

Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer

Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma

Cambridge University Hospitals NHS Foundation Trust

Nervous System Diseases

Neoplasm Metastasis

Necrosis

Neoplasms, Second Primary

Brain Neoplasms

Disease Attributes

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).

Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Post-op hypofractionated therapy or no radiation therapy

Radiation Therapy

Best medical management with steroid therapy

Steroid Therapy

Minimally invasive technique to necrotize intracranial lesions using the NeuroBlate® System (NBS)

Laser Interstitial Thermal Therapy

Christa Seligman

Beth Perry

Peter Fecci, MD

Wendy Jenkins

Adrian Laxton, MD

Allison Dymacek

Mark Hoeprich, MD

Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.

REMASTer: REcurrent Brain Metastases After SRS Trial

Determine the effectiveness of LITT using the NeuroBlate® System with or without repeat SRS on recurrent brain metastases, as measured by freedom from local progression.

Determine the effectiveness of LITT using the NeuroBlate System versus standard medical management as measured by time to steroid independence without escalation of care, measured in days from LITT procedure, defined as freedom from steroids for a period of four weeks without escalation of care.

Compare treatment approaches with respect to overall survival.

Compare treatment approaches with respect to FFLP or neurologic death

Monteris Medical

Blood and Lymph Conditions

Immune System Diseases

Hematologic Neoplasms

Graft vs Host Disease

Hematologic Diseases

Homologous Wasting Disease

Acute Graft Versus Host Disease

Lipid Regulating Agents

Leflunomide

Cholestyramine Resin

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Patients receive steroid therapy at the discretion of the treating physician. Beginning within 3 days of starting steroids, patients receive leflunomide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients who respond to leflunomide treatment will be tapered off from day 29 until day 56.

Cholestyramine

Monzr M. Al Malki

Monzr M Al Malki

This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.

PRIMARY OBJECTIVE:

I. Assess the safety and tolerability of leflunomide administration in transplant patients with diagnosis of acute graft-versus-host disease (GvHD) requiring systemic therapy, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration.

SECONDARY OBJECTIVES:

I. Obtain preliminary evidence of leflunomide activity against acute GvHD by estimating the overall response rate (ORR).

II. Obtain estimates of total steroid dose and length of therapy (area under curve).

III. Day +180 non-relapse mortality (NRM). IV. Overall survival (OS) and progression-free survival (PFS) at one-year. V. Rate and severity of infections during leflunomide administration.

EXPLORATORY OBJECTIVES:

I. Assess the clinical pharmacokinetics of teriflunomide (active metabolite of leflunomide).

II. Assess the presence of and percentage of immune cell subsets (including but not limited to Th17 and regulatory T cells) in blood during leflunomide administration.

III. Assess the changes in presence and levels of GvHD biomarkers and inflammatory cytokines in plasma during the course of treatment with leflunomide.

IV. Obtain a preliminary estimate of gut microbiome diversity at baseline (preferably before leflunomide administration), and then on days +14, +28, and +56.

OUTLINE:

Patients receive steroid therapy at the discretion of the treating physician. Beginning within 3 days of starting steroids, patients receive leflunomide orally (PO) once daily (QD) on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients who respond to leflunomide treatment will be tapered off from day 29 until day 56.

After completion of study treatment, patients are followed up at 28 days, 56 days, 100 days, and 6 months from last dose of leflunomide.

Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies

Pilot Trial of Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 5.0. Unacceptable toxicity (UT) evaluation period will be from starting first loading dose of leflunomide to occurrence of UTs, or stopping leflunomide due to graft versus host disease (GVHD) progression, or day +28, whichever comes first.

Patients who have partial or complete response will be counted as responders. Patients who have stable or progressive disease or withdraw the study early before response assessment is completed will be counted as non-responders.

Will be calculated from day 0 to date of non-disease death from causes other than relapse or progression. Disease relapse/progression will be counted as a competing risk. NRM will be censored at the last follow-up date if patients are alive and free of disease relapse/progression.

FFS will be censored on the last follow-up if patient is still alive and free of any event of interest.

PFS will be censored on the last disease assessment date if patient is still alive and disease relapse/progression is not observed.

The rate of bloodstream infections will be evaluated during leflunomide administration.

The severity of infections will be evaluated during leflunomide administration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer	NCT00978549	Adenocarcinoma ... Esophageal Canc... Gastric Cancer Nausea and Vomi... Pain	docetaxel steroid therapy questionnaire a... nausea and vomi... pain therapy quality-of-life... standard follow... radiation thera...	18 Years -	National Cancer Institute (NCI)
REMASTer: REcurrent Brain Metastases After SRS Trial	NCT05124912	Brain Metastase... Radiation Necro... Recurrent Tumor Recurrent Metas...	Radiation Thera... Steroid Therapy Laser Interstit...	18 Years -	Monteris Medical
Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies	NCT05443425	Acute Graft Ver... Hematopoietic a...	Cholestyramine Leflunomide Steroid Therapy	18 Years -	City of Hope Medical Center
Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer	NCT00978549	Adenocarcinoma ... Esophageal Canc... Gastric Cancer Nausea and Vomi... Pain	docetaxel steroid therapy questionnaire a... nausea and vomi... pain therapy quality-of-life... standard follow... radiation thera...	18 Years -	National Cancer Institute (NCI)
Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies	NCT05443425	Acute Graft Ver... Hematopoietic a...	Cholestyramine Leflunomide Steroid Therapy	18 Years -	City of Hope Medical Center

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