Mechlorethamine

Generic Name: Mechlorethamine

Brand Names: Valchlor, Ledaga

Drug Type: Small Molecule

Chemical Formula: C_₅H_₁₁Cl_₂N

CAS Number: 51-75-2

Unique Ingredient Identifier: 50D9XSG0VR

Background: A vesicant and necrotizing irritant destructive to mucous membranes, mechlorethamine is an alkylating drug. It was formerly used as a war gas. The hydrochloride is used as an antineoplastic in Hodgkin's disease and lymphomas. It causes severe gastrointestinal and bone marrow damage.

The FDA granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel on August 23, 2013 for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Each tube of Valchlor contains 0.016% of mechlorethamine which is equivalent to 0.02% mechlorethamine HCl.

Indication: 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. Also for the palliative treatment of metastatic carcinoma resulting in effusion.

Associated Conditions: Bronchogenic Carcinoma, Chronic Lymphocytic Leukemia, Hodgkins Disease (HD), Lymphoma, Diffuse, Mycosis Fungoides (MF), Polycythemia Vera (PV), Stage I Mycosis Fungoides, Malignant effusion

Clinical Trials

Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: gemcitabine hydrochloride
Drug: ifosfamide
Drug: mechlorethamine hydrochloride
Drug: melphalan
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Drug: vinorelbine tartrate
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation
Radiation: total-body irradiation

First Posted Date: 2007-12-17

Last Posted Date: 2023-09-28

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 25

Registration Number: NCT00574496

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides

Phase 2

Completed

Conditions: Mycosis Fungoides

Interventions: Drug: 0.04% Mechlorethamine gel

First Posted Date: 2007-09-26

Last Posted Date: 2012-08-09

Lead Sponsor: Yaupon Therapeutics

Target Recruit Count: 100

Registration Number: NCT00535470

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Stanford University Medical Center, Stanford, California, United States
🇺🇸
Columbia University, Dept of Dermatology, New York, New York, United States

and more 8 locations

Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma

Phase 3

Active, not recruiting

Conditions: Lymphoma

First Posted Date: 2006-09-21

Last Posted Date: 2024-02-22

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 1158

Registration Number: NCT00379041

Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Phase 2

Completed

Conditions: Hodgkin's Lymphoma

Interventions: Drug: Adriamycin®
Drug: Vinblastine
Drug: Nitrogen Mustard
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Bleomycin
Drug: Etoposide
Drug: Prednisone
Biological: G-CSF
Procedure: Radiotherapy

First Posted Date: 2006-07-14

Last Posted Date: 2023-09-22

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 81

Registration Number: NCT00352027

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Stanford University Medical Center, Palo Alto, California, United States
🇺🇸
Rady Children's Hospital San Diego, San Diego, California, United States

and more 3 locations

RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease

Phase 3

Active, not recruiting

Conditions: Lymphoma

First Posted Date: 2004-07-26

Last Posted Date: 2024-02-22

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 615

Registration Number: NCT00002462

Locations: 🇮🇹
Centro di Riferimento Oncologico - Aviano, Aviano, Italy
🇫🇷
Hopital Necker, Paris, France
🇳🇱
Integraal Kankercentrum Amsterdam, Amsterdam, Netherlands

and more 53 locations

Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: MOPP Regimen
Drug: Leucovorin Calcium
Drug: Mechlorethamine Hydrochloride
Drug: Methotrexate
Drug: Prednisone
Drug: Procarbazine Hydrochloride
Drug: Vincristine Sulfate
Procedure: Conventional Surgery

First Posted Date: 2004-04-22

Last Posted Date: 2013-02-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 4

Registration Number: NCT00002463

Locations: 🇺🇸
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease

Phase 2

Completed

Conditions: Lymphoma

First Posted Date: 2004-04-06

Last Posted Date: 2013-05-15

Lead Sponsor: Stanford University

Registration Number: NCT00002714

Locations: 🇺🇸
Stanford University Medical Center, Stanford, California, United States

Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection

Phase 2

Conditions: Lymphoma

First Posted Date: 2003-04-23

Last Posted Date: 2013-09-20

Lead Sponsor: Centro di Riferimento Oncologico - Aviano

Target Recruit Count: 30

Registration Number: NCT00003262

Locations: 🇮🇹
Centro di Riferimento Oncologico - Aviano, Aviano, Italy

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Phase 3

Completed

Conditions: Lymphoma

Interventions: Drug: Doxorubicin
Drug: Bleomycin
Drug: Vinblastine
Drug: Dacarbazine
Drug: Vincristine
Radiation: Radiotherapy
Drug: Mechlorethamine
Drug: Etoposide
Drug: Prednisone
Drug: Cyclophosphamide

First Posted Date: 2003-01-27

Last Posted Date: 2023-06-29

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 854

Registration Number: NCT00003389

Locations: 🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇺🇸
Piedmont Hospital, Atlanta, Georgia, United States
🇺🇸
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

and more 529 locations

Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma

Phase 3

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-09-20

Lead Sponsor: Mount Vernon Cancer Centre at Mount Vernon Hospital

Target Recruit Count: 850

Registration Number: NCT00041210

Locations: 🇬🇧
Pinderfields General Hospital, Wakefield, Scotland, United Kingdom
🇬🇧
Aintree University Hospital, Liverpool, England, United Kingdom
🇬🇧
City Hospital - Birmingham, West Bromwich, England, United Kingdom

and more 34 locations

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