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Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers

2014-08-27 03:58:32 | BioPortfolio

Summary

RATIONALE: Thalidomide may kill tumor cells by stopping the growth of new blood vessels to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and cyclophosphamide in treating children who have recurrent or refractory childhood cancers.

Description

OBJECTIVES: I. Determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies.

OUTLINE: Patients receive oral thalidomide 4 times daily. Cyclophosphamide is administered IV over 1 hour once every 4 weeks, beginning on the same day as thalidomide. Treatment continues in the absence of unacceptable toxicity or disease progression. Tumor response is assessed every 3 months.

PROJECTED ACCRUAL: A total of 45-80 patients will be accrued for this study within 2 years.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

cyclophosphamide, thalidomide

Location

Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10021

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:32-0400

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PubMed Articles [19201 Associated PubMed Articles listed on BioPortfolio]

A validated LC-MS/MS method for the simultaneous determination of thalidomide and its two metabolites in human plasma: Application to a pharmacokinetic assay.

An accurate and sensitive LC-MS/MS method for determining thalidomide, 5-hydroxy thalidomide and 5'-hydroxy thalidomide in human plasma was developed and validated using umbelliferone as an internal s...

Middle-aged individuals with thalidomide embryopathy have undergone few surgical limb procedures and demonstrate a high degree of physical independence.

Thalidomide is known to have induced thalidomide embryopathy (TE) in more than 10,000 live-born children worldwide between 1957-1962.

A phase I clinical trial of RNF43 peptide-related immune cell therapy combined with low-dose cyclophosphamide in patients with advanced solid tumors.

The objective of this study was to investigate the safety and the tolerability of combined cellular immunotherapy with low-dose cyclophosphamide (CPA) in patients with advanced solid tumors. This stud...

Thalidomide induces apoptosis during early mesodermal differentiation of human induced pluripotent stem cells.

Thalidomide was once administered to pregnant women as a mild sedative; however, it was subsequently shown to be strongly teratogenic. Recently, there has been renewed interest in thalidomide because ...

Thalidomide alleviates postoperative pain and spatial memory deficit in aged rats.

Pain is a major risk factor of post-operative cognitive dysfunction (POCD) in aged population. We investigated the effects of thalidomide, an anti-inflammatory and analgesic drug, on POCD in aged rats...

Medical and Biotech [MESH] Definitions

A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

A rare but highly lethal childhood tumor found almost exclusively in infants. Histopathologically, it resembles RHABDOMYOSARCOMA but the tumor cells are not of myogenic origin. Although it arises primarily in the kidney, it may be found in other parts of the body. The rhabdoid cytomorphology is believed to be the expression of a very primitive malignant cell. (From Holland et al., Cancer Medicine, 3d ed, p2210)

A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.

A malignant kidney tumor, caused by the uncontrolled multiplication of renal stem (blastemal), stromal (STROMAL CELLS), and epithelial (EPITHELIAL CELLS) elements. However, not all three are present in every case. Several genes or chromosomal areas have been associated with Wilms tumor which is usually found in childhood as a firm lump in a child's side or ABDOMEN.

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