Advertisement

Topics

Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck

2014-08-27 03:55:21 | BioPortfolio

Summary

The purpose of this study will be to determine the safety and tolerability of intratumoral M4N. Patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4 weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated for 6 weeks, and finally, 8 weeks.

Study Design

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

Conditions

Head and Neck Neoplasms

Intervention

Tetra-O-Methyl Nordihydroguaiaretic Acid (M4N or EM-1421)

Location

MUSC
Charleston
South Carolina
United States
29475

Status

Completed

Source

Erimos Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:21-0400

Clinical Trials [2583 Associated Clinical Trials listed on BioPortfolio]

Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma

RATIONALE: Drugs used in chemotherapy, such as tetra-O-methyl nordihydroguaiaretic acid (EM-1421), work in different ways to stop the growth of tumor cells, either by killing the cells or ...

Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects an...

Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?

To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces blood loss during head and neck surgery.

Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer

This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA administration and assessing the proportion of patients who experience a 50% decline in PSA.

Dose Escalation Study of EM-1421 for the Treatment of Recurrent or Refractory Solid Tumors

This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV) for five consecutive days every 28 days to patients with solid tumors refractory to current th...

PubMed Articles [10775 Associated PubMed Articles listed on BioPortfolio]

Application of three-dimensional reconstruction of the enhanced CT with iPlan CMF software in head and neck neoplasms.

Three-dimensional reconstruction of the enhanced CT is increasingly becoming a valuable tool in head and neck neoplasms. The aim of this study is to reconstruct three-dimensional imaging of tumor and ...

Updates on Immunohistochemical and Molecular Markers in Selected Head and Neck Diagnostic Problems.

- The head and neck regions have complex anatomic structures. They are not exempted from the rare occurrences of highly unusual, diagnostically challenging malignant neoplasms and mimickers.

Change in alcohol and tobacco consumption after a diagnosis of head and neck cancer: Findings from head and neck 5000.

Tobacco and alcohol consumption are risk factors for developing head and neck cancer, and continuation postdiagnosis can adversely affect prognosis. We explored changes to these behaviors after a head...

Justification of routine venous thromboembolism prophylaxis in head and neck cancer reconstructive surgery.

Venous thromboembolism (VTE) is a preventable complication in which early ambulation is expected after head and neck surgery. Thus, the role of VTE prophylaxis is questionable and needs further assess...

Head and neck lymphedema management: Evaluation of a therapy program.

The purpose of this pilot study was to examine a therapeutic intervention for head and neck lymphedema. The 22-week intervention involved therapist-led care and participant self-management. Effectiven...

Medical and Biotech [MESH] Definitions

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

A potent lipoxygenase inhibitor that interferes with arachidonic acid metabolism. The compound also inhibits formyltetrahydrofolate synthetase, carboxylesterase, and cyclooxygenase to a lesser extent. It also serves as an antioxidant in fats and oils.

Discharge of cerebrospinal fluid through the nose. Common etiologies include trauma, neoplasms, and prior surgery, although the condition may occur spontaneously. (Otolaryngol Head Neck Surg 1997 Apr;116(4):442-9)

A plant genus of the family ZYGOPHYLLACEAE. It is sometimes called chaparral but that is a generic word which is used with a number of other plants. Members contain NORDIHYDROGUAIARETIC ACID.

More From BioPortfolio on "Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...


Searches Linking to this Trial