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A Phase II Study of MS-275, in Combination With GM-CSF Treating Relapsed and Refractory Myeloid Malignancies

2014-08-27 03:38:51 | BioPortfolio

Summary

This research is being done to see if the combination of sargramostim and MS-275 will help to improve the bone marrow function of people with myelodysplastic syndrome (MDS) or acute myeloid leukemia(AML).

It will also determine the side effects of this combination.

Description

MDS is an abnormality of the bone marrow and blood cells that may develop into cancer.

AML is a cancer of the bone marrow and blood cells. Both result in problems making normal blood cells. The cells in the bone marrow do not undergo the normal expected patterns of growth or maturation that is called “differentiation.” Because of this, they do not work very well. People with these problems often need blood transfusions and are at high risk for infections and bleeding.

Treatment options for MDS and AML are often limited due to their side effects. We hope to develop combinations of drugs that will help the bone marrow function better without many of the side effects of traditional chemotherapy treatments.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Myelodysplastic Syndrome

Intervention

MS-275, GM-CSF

Location

Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
United States
21231

Status

Not yet recruiting

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:51-0400

Clinical Trials [1185 Associated Clinical Trials listed on BioPortfolio]

Erlotinib Study for Myelodysplastic Syndrome (MDS)

The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food an...

Amifostine in Treating Patients With Myelodysplastic Syndrome

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Myelodysplastic Syndrome--CDA-2 Hematological Improvement National Affirmation Study

This Study aims to evaluate the efficacy and safety of CDA-2 in the treatment of International Prognostic Scoring System (IPSS) Lower/Intermediate-risk myelodysplastic syndrome (MDS) in Ch...

Study of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome (MDS)

The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.

Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome

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PubMed Articles [4694 Associated PubMed Articles listed on BioPortfolio]

Clonal cytogenetic abnormalities of undetermined significance.

Myelodysplastic syndromes are a group of hematopoietic stem cell diseases characterized by cytopenia(s), morphological dysplasia, and clonal hematopoiesis. In some patients, the cause of cytopenia(s) ...

Mutation Clearance after Transplantation for Myelodysplastic Syndrome.

Allogeneic hematopoietic stem-cell transplantation is the only curative treatment for patients with myelodysplastic syndrome (MDS). The molecular predictors of disease progression after transplantatio...

Usefulness of tocilizumab for treating rheumatoid arthritis with myelodysplastic syndrome: A case report and literature review.

Dysregulated immune function in rheumatoid arthritis (RA) might lead to the development of myelodysplastic syndrome (MDS). Serum interleukin-6 (IL-6) concentrations are increased in both RA and MDS pa...

Gastric carcinoma subsequent to myelodysplastic syndrome with t (1; 19) chromosome translocation: A rare case report and its potential mechanisms.

Myelodysplastic syndrome (MDS) is a heterogeneous malignant hematologic disease with median overall survival ranging from six months to more than ten years. Solid tumor rarely occurs in combination wi...

Risk of acute myeloid leukemia and myelodysplastic syndrome after autotransplants for lymphomas and plasma cell myeloma.

Exposures to DNA-damaging drugs and ionizing radiations increase risks of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Medical and Biotech [MESH] Definitions

Clonal myeloid disorders that possess both dysplastic and proliferative features but are not properly classified as either MYELODYSPLASTIC SYNDROMES or MYELOPROLIFERATIVE DISORDERS.

A myelodysplastic-myeloproliferative disease characterized by monocytosis, increased monocytes in the bone marrow, variable degrees of dysplasia, but an absence of immature granulocytes in the blood.

Condition with a variable constellation of phenotypes due to deletion polymorphisms at chromosome location 22q11. It encompasses several syndromes with overlapping abnormalities including the DIGEORGE SYNDROME, VELOCARDIOFACIAL SYNDROME, and CONOTRUNCAL AMOMALY FACE SYNDROME. In addition, variable developmental problems and schizoid features are also associated with this syndrome. (From BMC Med Genet. 2009 Feb 25;10:16) Not all deletions at 22q11 result in the 22q11deletion syndrome.

Rare congenital disorder with multiple anomalies including: characteristic dysmorphic craniofacial features, musculoskeletal abnormalities, neurocognitive delay, and high prevalence of cancer. Germline mutations in H-Ras protein can cause Costello syndrome. Costello syndrome shows early phenotypic overlap with other disorders that involve MAP KINASE SIGNALING SYSTEM (e.g., NOONAN SYNDROME and cardiofaciocutaneous syndrome).

An autosomal dominant aneurysm with multisystem abnormalities caused by increased TGF-BETA signaling due to mutations in type I or II of TGF-BETA RECEPTOR. Additional craniofacial features include CLEFT PALATE; CRANIOSYNOSTOSIS; HYPERTELORISM; or bifid uvula. Phenotypes closely resemble MARFAN SYNDROME; Marfanoid craniosynostosis syndrome (Shprintzen-Goldberg syndrome); and EHLERS-DANLOS SYNDROME.

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