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Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors

2014-08-27 03:58:33 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of intoplicine in treating patients who have advanced or metastatic solid tumors.

Description

OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in these patients. III. Determine the principal and dose limiting toxicities of intoplicine in these patients, and determine the duration and reversibility of the toxicities. IV. Determine the magnitude of plasma concentrations that are achieved and maintained on this regimen and relate this parameter to toxicity outcome and antitumor activity. V. Determine preliminary evidence of antitumor activity of intoplicine in these patients.

OUTLINE: This is a dose escalation study. The first 3 patients receive intoplicine IV by continuous infusion for 5 days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Subsequent cohorts of 3-6 patients receive escalating doses of intoplicine, first by increasing the number of days that the drug is infused to 10, 15, and 21, then by increasing the dosage and keeping the infusion time constant at 21 days. The intolerable dose level is defined as the lowest dose at which at least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

intoplicine

Location

Brooke Army Medical Center
Fort Sam Houston
Texas
United States
78234

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:33-0400

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PubMed Articles [21467 Associated PubMed Articles listed on BioPortfolio]

An Economical, Quantitative, and Robust Protocol for High-Throughput T Cell Receptor Sequencing from Tumor or Blood.

The T cell receptor repertoire provides a window to the cellular adaptive immune response within a tumor, and has the potential to identify specific and personalized biomarkers for tracking host respo...

Tumor-Infiltrating Podoplanin+ Fibroblasts Predict Worse Outcome in Solid Tumors.

Tumor-infiltrating fibroblasts are a heterogeneous population, and different subpopulations play differential roles in tumor microenvironment. However, the prognostic role of podoplanin+ fibroblasts i...

Expressing Cytotoxic Compounds in Escherichia coli Nissle 1917 for Tumor-targeting Therapy.

Abnormal blood vessels and hypoxic and necrotic regions are common features of solid tumors and related to the malignant phenotype and therapy resistance. Certain obligate or facultative anaerobic bac...

Np95/Uhrf1 regulates tumor suppressor gene expression of neural stem/precursor cells, contributing to neurogenesis in the adult mouse brain.

Adult neurogenesis is a process of generating new neurons from neural stem/precursor cells (NS/PCs) in restricted adult brain regions throughout life. It is now generally known that adult neurogenesis...

On the relation between MR spectroscopy features and the distance to MRI-visible solid tumor in GBM patients.

To improve the detection of peritumoral changes in GBM patients by exploring the relation between MRSI information and the distance to the solid tumor volume (STV) defined using structural MRI (sMRI).

Medical and Biotech [MESH] Definitions

A solid, unencapsulated tumor of the KIDNEY composed of spindle mesenchymal cells that resemble FIBROBLASTS or muscle cells. The homogeneous mass typically extends into the renal parenchyma and replaces most of the kidney. In most cases, mesoblastic nephroma is benign and occurs in the fetus or newborn, and rarely in the older child or the adult.

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 cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)

A solid tumor consisting of a dense infiltration of MAST CELLS. It is generally benign.

Diseases of the respiratory system in general or unspecified or for a specific respiratory disease not available.

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