Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Rare Diseases

Recurrence

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Central Nervous System Diseases

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

given intrathecally in induction phase every 15 days until CSF response for up to 7 injections. Then it is given every 4 weeks during consolidation phase while patient awaiting bone marrow transplant. For those patients who are not candidates for a bone marrow transplant, the drug will be given every 3 months for 4 administrations (maintenance therapy)

liposomal cytarabine

Rosanna Parasole, M.D.

Massimo Di Maio, M.D.

Francesco Perrone, M.D., Ph.D.

A. Pession

William Morello

E. Strocchi

The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in children and adolescents.

Liposomal cytarabine (DepoCyte) is a new formulation of the drug cytarabine, a drug commonly used in the treatment of ALL. This formulation of the drug can be given intrathecally (into the spinal fluid), and is released slowly over a longer period, about two weeks. This allows a longer exposure of the drug to the central nervous system, and requires fewer intrathecal injections for the patient.

Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children

Multicentered Phase II Study Evaluating the Activity and Toxicity of Liposomal Cytarabine in the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia With Resistent or Relapsed Central Nervous System Involvement

date of reaching CSF response is the first date of two consecutive negative cytomorphologic exams of CSF

duration of response is the length of time in days from the date of the CSF response to the date of the first positive cytomorphologic CSF exam

Santobono-Pausilpon Hospital

IRCCS Azienda Ospedaliero-Universitaria di Bologna

University of Bologna

National Cancer Institute, Naples

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Cancer Pain

Pain

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neurologic Manifestations

Pancreatic Cancer

Analgesics

Psychotropic Drugs

Channel Blockers

Anticonvulsants

Central Nervous System Depressants

Anti-Inflammatory Agents

Antirheumatic Agents

Duloxetine Hydrochloride

Pregabalin

Gabapentin

Anti-Inflammatory Agents, Non-Steroidal

Narcotics

These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.

These subjects will be treated with conventional medical management to treat their pain.

The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.

Intrathecal Drug Delivery System

Treatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain.

Conventional Medical Management

Daniel R Kloster, MD

The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.

This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.

There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.

A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.

A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

Level of pain is rated on the visual analog scale. Pain scores after three months of therapy will be compared to baseline pain scores to see if there is a difference.

Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.

Difference in quality of life between treatment groups.

Difference between treatment group in the number of cancer treatment initiated during the study

Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study

Adverse events reported by each treatment group will be summarized.

Flowonix Medical

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children	NCT01593488	Acute Lymphobla...	liposomal cytar...	18 Years -	National Cancer Institute, Naples
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain	NCT02578459	Pain Management Cancer Pain	Intrathecal Dru... Conventional Me...	22 Years -	Flowonix Medical

Spots Global Cancer Trial Database for intrathecal therapy