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Mustargen (Mechlorethamine Hydrochloride (Nitrogen Mustard)) - Summary



MUSTARGEN® (mechlorethamine HCl) should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of mechlorethamine (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. Extravasation of the drug into subcutaneous tissues results in a painful inflammation. The area usually becomes indurated and sloughing may occur. If leakage of drug is obvious, prompt infiltration of the area with sterile isotonic sodium thiosulfate (1/6 molar) and application of an ice compress for 6 to 12 hours may minimize the local reaction. For a 1/6 molar solution of sodium thiosulfate, use 4.14 g of sodium thiosulfate per 100 mL of Sterile Water for Injection or 2.64 g of anhydrous sodium thiosulfate per 100 mL or dilute 4 mL of Sodium Thiosulfate Injection (10%) with 6 mL of Sterile Water for Injection.



MUSTARGEN, an antineoplastic nitrogen mustard also known as HN2 hydrochloride, is a nitrogen analog of sulfur mustard.


MUSTARGEN, administered intravenously, is indicated for the palliative treatment of Hodgkin’s disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.

MUSTARGEN, administered intrapleurally, intraperitoneally, or intrapericardially, is indicated for the palliative treatment of metastatic carcinoma resulting in effusion.

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Published Studies Related to Mustargen (Mechlorethamine)

Comparative study of two mechlorethamine, vincristine, procarbazine, and prednisone derived chemotherapeutic protocols for the management of pediatric Hodgkin lymphoma (HL): single-center 5-year experience. [2010.04]
We aimed for the comparison of two protocols (OAP and COMP) as chemotherapy treatment in children with Hodgkin lymphoma (HL). A total of 119 children newly diagnosed with HD were divided to receive either the anthracycline-based OAP protocol or the alkylating-agent-based COMP protocol... Patients treated with the COMP protocol achieved a better response and less toxicity but with similar survival to those given the OAP protocol.

Tetracycline compared with mechlorethamine in the treatment of malignant pleural effusions. A randomized trial. [1994.08]
Pleural sclerosis after tube thoracostomy was performed in 40 patients with malignant pleural effusions. The patients were randomly allocated to intrapleural therapy with tetracycline or mechlorethamine...

Comparison of total nodal irradiation versus combined sequence of mantle irradiation with mechlorethamine, vincristine, procarbazine, and prednisone in clinical stages I and II Hodgkin's disease: experience of the European Organization for Research and Treatment of Cancer. [1988]
The H5 study of supradiaphragmatic Hodgkin's disease in clinical stages I-II consisted of two controlled trials adapted to patients considered to have either favorable or unfavorable characteristics, based on prognostic factors identified in two former studies by the European Organization for Research and Treatment of Cancer...

Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. [2013]
hydrochloride, 0.02%, gel in mycosis fungoides... CONCLUSION: The use of a novel mechlorethamine, 0.02%, gel in the treatment of

Estimation of the action of three different mechlorethamine doses on biochemical parameters during experimentally induced pleuritis in rats. [2011.03]
Nitrogranulogen (NTG) may modify the character of inflammatory reactions... Our studies show that the different doses of NTG have distinct effects on the inflammatory reaction.

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Clinical Trials Related to Mustargen (Mechlorethamine)

Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2) [Completed]
The purpose of the study is to validate a new reference marker for evaluation of renal function (glomerular filtration rate).

Observational US Study Assessing Outcomes, Treatment Patterns, AEs, QOL in MF-CTCL Patients and Treated With Valchlor [Recruiting]
The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study that longitudinally follows patients with MF-CTCL who are receiving therapy with Valchlor. Patients will be followed prospectively for a maximum of 1 year from the date of signed informed consent (enrollment) until end of study. Continuation in the study is not contingent on continuation of Valchlor.

Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides [Completed]
This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).

An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides [Completed]
To evaluate the efficacy and safety of topical application of MCH 0. 04% in a propylene glycol ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0. 02% in a PG or AP ointment who did not achieve a complete response.

Phase II Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma Patients [Completed]
This is a single-center, open label, phase II study aimed at testing the activity of multiple cycles of ITF2357 followed by Mechlorethamine administered to patients with relapsed/refractory Hodgkin's lymphoma. Patients will receive a maximum of twelve 3-week cycles of ITF2357 followed by Mechlorethamine according to the following schema:

- ITF2357, 50 mg every 6 hours, per os, days 1 - 3

- Mechlorethamine, 6 mg/sqm, intravenously , day 4

Study therapy will be administered every 21 days as long as there is no evidence of progressive disease or unacceptable adverse events or patient's request to discontinue treatment occurs, but in any case for a maximum of 12 cycles. Decision regarding the continuation of ITF2357/Mechlorethamine therapy will be made on (i)the basis of tumor reassessment following cycles 2, 6, 9, and 12 and (ii) the occurrence of toxicity. Tumor response will be evaluated according to the International Working Group response criteria HL. Treatment will be administrated on an outpatient basis and patients will be followed regularly with physical and laboratory tests, as specified in the protocol; in case of hospitalisation, the treatment will be continued or interrupted according to the Investigators' decision. The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the study is about 24 months.

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Page last updated: 2014-11-30

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