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1. Introduction to investigational treatment(s) and other study treatment(s)
1.1 Overview of gemcitabine Gemcitabine (29,29-difluoro 29-deoxycytidine, dFdC) which developed from cytosine arabinoside (Ara-C) is an nucleoside analog used as chemotherapy. It was intended as an antiviral drug in
Tuberous sclerosis complex (TSC) is an autosomal dominant disorder caused by mutations in tuberous sclerosis complex 1 (TSC1) or TSC2 tumor suppressor genes. TSC is characterized by tumors in a wide range of tissues, seizures, mental retardation, autism, and organ failure. Lymphangioleiomyomatosis
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
Busulfan (Bu) is a key compound in conditioning myeloablative regimens for patients undergoing hematopoietic stem cell transplantation (HSCT). Bu has been long used for the
Describe succinctly and clearly the past findings which justify the plan for this project. A summary of the relevant literature in the area of interest and reports of previous studies should be included.
For majority of lymphoma patients who relapse after complete response or who are primary
Fifty percent of patients with aggressive B cell non-Hodgkin lymphomas are expected to relapse after initial standard chemotherapy. There is no standard salvage regimen for patients with relapsed or refractory disease and at least 75% of patients are expected to succumb to their condition with the
Adjuvant chemotherapy for high grade soft tissue sarcomas is controversial. Given the fact that approximately 50% of patients receiving optimum treatment will recur in three years and die of recurrence within five years, smarter adjuvant options are needed. One such treatment option would be to
PHASE I
The Study Drugs:
Dasatinib is designed to change the function of certain genes. By changing the function of these genes, it may prevent cancer from growing and spreading. It is also designed to block or lower the activity of one or more tumor-causing proteins responsible for the uncontrolled
The Study Drugs:
Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Cyclophosphamide is designed to interfere with
Acute lymphoblastic leukemia (ALL) is the most prevalent childhood malignant disease. Survival has improved from 5-10% in the early 1960s to over 80% at present. Historically, the central nervous system (CNS) was the most common site of leukemia relapse. However, major improvement in cure rates was
OBJECTIVES:
- To determine the efficacy of a preparative regimen comprising dose targeted busulfan, etoposide, and fractionated total-body irradiation followed by allogeneic hematopoietic stem cell or bone marrow transplantation in patients with advanced hematologic malignancies.
- To determine the
All participants will be treated with valproic acid (VPA) at a starting dose of 15 mg/kg/day orally in divided doses. This dose produces a VPA plasma level of 346-693 μM and is the recommended starting dose for patients with seizure disorder. Each week a pre-dose serum VPA level will be determined
The Study Drugs:
Valproic acid is designed for use as an anti-seizure medication. It is thought to also have anticancer activity by activating ("turning on") tumor-fighting genes, which may cause cancer cell death.
Dasatinib is designed to change the function of genes. By changing the function of
Pentostatin (deoxycoformycin) is a purine analogue that is currently indicated for the treatment of chemo-naïve or interferon-refractory hairy cell leukemia. Pentostatin represents an ideal agent for conditioning recipients before allogeneic hematopoietic cell transplantation (HCT) due to its
Decitabine and valproic acid are both designed to cause changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may cause cancer cells to die. Researchers want to see if a combination of valproic acid with decitabine can help improve disease response