CLINICAL TRIALS PROFILE FOR MECHLORETHAMINE HYDROCHLORIDE

All Clinical Trials for Mechlorethamine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002462 ↗	RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease	Active, not recruiting	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1989-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin's disease.
NCT00002463 ↗	Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors	Completed	National Cancer Institute (NCI)	Phase 2	1989-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of methotrexate, mechlorethamine, vincristine, procarbazine, and prednisone in treating children with astrocytomas or primitive neuroectodermal tumors.
NCT00002463 ↗	Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors	Completed	M.D. Anderson Cancer Center	Phase 2	1989-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of methotrexate, mechlorethamine, vincristine, procarbazine, and prednisone in treating children with astrocytomas or primitive neuroectodermal tumors.
NCT00002714 ↗	Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 2	1995-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage Hodgkin's disease.
NCT00002714 ↗	Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease	Completed	Stanford University	Phase 2	1995-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage Hodgkin's disease.
NCT00002715 ↗	Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1989-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.
NCT00002715 ↗	Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma	Completed	Stanford University	Phase 2	1989-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.

Clinical Trial Conditions for Mechlorethamine Hydrochloride

Condition Name

Condition Name for Mechlorethamine Hydrochloride
Intervention	Trials
Lymphoma	9
Mycosis Fungoides	5
Hodgkin Lymphoma	2
Cutaneous T-cell Lymphoma	2

Condition MeSH

Condition MeSH for Mechlorethamine Hydrochloride
Intervention	Trials
Lymphoma	13
Hodgkin Disease	12
Mycosis Fungoides	6
Mycoses	6

Clinical Trial Locations for Mechlorethamine Hydrochloride

Trials by Country

Trials by Country for Mechlorethamine Hydrochloride
Location	Trials
United States	84
Canada	9
United Kingdom	4
Italy	3
France	1

Trials by US State

Trials by US State for Mechlorethamine Hydrochloride
Location	Trials
California	7
New York	6
Illinois	5
Pennsylvania	4
Texas	4

Clinical Trial Progress for Mechlorethamine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Mechlorethamine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	13

Clinical Trial Status

Clinical Trial Status for Mechlorethamine Hydrochloride
Clinical Trial Phase	Trials
Completed	8
Unknown status	5
Active, not recruiting	4

Clinical Trial Sponsors for Mechlorethamine Hydrochloride

Sponsor Name

Sponsor Name for Mechlorethamine Hydrochloride
Sponsor	Trials
National Cancer Institute (NCI)	5
Yaupon Therapeutics	2
European Organisation for Research and Treatment of Cancer - EORTC	2

Sponsor Type

Sponsor Type for Mechlorethamine Hydrochloride
Sponsor	Trials
Other	20
Industry	9
NIH	7

Mechlorethamine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Mechlorethamine hydrochloride, also known as nitrogen mustard, is an antineoplastic agent that has been used for decades in the treatment of various cancers, particularly mycosis fungoides, a type of cutaneous T-cell lymphoma (CTCL). Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Recent Clinical Trials

One of the significant clinical trials for mechlorethamine hydrochloride was the randomized, active-control, observer-blinded clinical trial (Clinical Trial 2005NMMF-201-US). This trial evaluated the safety and efficacy of a 0.02% mechlorethamine hydrochloride gel (Valchlor) in patients with early-stage mycosis fungoides. The trial involved 255 patients and showed that topical mechlorethamine was applied once daily for a median duration of approximately 52 weeks. The most common adverse event was dermatitis, reported in 57% of patients in the Valchlor arm and 58% in the control arm[2].

Safety and Efficacy Findings

The trial highlighted several key safety findings:

• Dermatitis was a prevalent adverse event, with moderately-severe or severe dermatitis reported in 23% of patients in the Valchlor arm and 17% in the control arm.
• Eleven of 255 patients (4%) developed non-melanoma skin cancer (nMSC) during or after the trial, with risk factors including age ≥ 65 years and prior history of nMSC[2].

Pharmacokinetics

No detectable concentrations of mechlorethamine were observed in plasma samples from patients treated with the 0.02% gel, indicating minimal systemic exposure. This was a crucial finding as it supported the topical use of the drug without significant systemic side effects[1].

Market Analysis

Current Market Status

Mechlorethamine hydrochloride, particularly the 0.02% gel formulation (Valchlor), has been approved by the FDA for the topical treatment of Stage IA and IB mycosis fungoides in patients who have received at least one prior skin-directed therapy. This approval marked a significant milestone, as it formalized the use of a drug that had been used off-label for nearly 50 years[1][4].

Market Demand

The demand for mechlorethamine hydrochloride is driven by the need for effective treatments for mycosis fungoides and other cutaneous T-cell lymphomas. Given the limited treatment options for these conditions, the approval of Valchlor has filled a critical gap in the market.

Competitive Landscape

The market for topical treatments of CTCL is relatively niche but growing. Valchlor, being the first FDA-approved topical formulation of mechlorethamine hydrochloride, holds a significant market share. However, the presence of other treatments and ongoing research into new therapies keeps the competitive landscape dynamic.

Market Projections

Growth Potential

The market for mechlorethamine hydrochloride is expected to grow due to several factors:

• Increasing Incidence of CTCL: The incidence of cutaneous T-cell lymphomas is rising, which will drive the demand for effective treatments.
• Approval and Adoption: The FDA approval of Valchlor has increased its adoption rate among dermatologists and oncologists.
• Research and Development: Ongoing clinical trials and research into new formulations and indications could further expand the market[4].

Challenges and Opportunities

Despite the growth potential, there are challenges to consider:

• Side Effects: The high incidence of dermatitis and the risk of non-melanoma skin cancer are significant concerns that need to be managed.
• Product Quality: Ensuring the quality and consistency of the commercial product lots is crucial, as highlighted by the FDA's recommendations for additional clinical trials to establish long-term safety[2].

Future Indications

Mechlorethamine hydrochloride is being studied for other types of cancer, which could expand its market reach. For example, its use in treating psoriasis and other skin conditions has been explored, although these are not yet approved indications[3][4].

Key Takeaways

• Clinical Trials: Recent trials have established the safety and efficacy of mechlorethamine hydrochloride 0.02% gel for early-stage mycosis fungoides.
• Market Approval: The FDA approval of Valchlor has solidified its position in the market for CTCL treatments.
• Growth Potential: The market is expected to grow due to increasing incidence of CTCL and ongoing research into new indications.
• Challenges: Managing side effects and ensuring product quality are critical for long-term market success.

FAQs

What is mechlorethamine hydrochloride used for?

Mechlorethamine hydrochloride is used for the topical treatment of Stage IA and IB mycosis fungoides, a type of cutaneous T-cell lymphoma, and is also being studied for other types of cancer[1][4].

What are the common side effects of mechlorethamine hydrochloride?

The most common side effect is dermatitis, with moderately-severe or severe cases reported in a significant portion of patients. There is also a risk of non-melanoma skin cancer[2].

Is mechlorethamine hydrochloride systemically absorbed?

No, clinical trials have shown that there is no detectable systemic exposure to mechlorethamine when used in a 0.02% gel formulation[1].

What is the current market status of mechlorethamine hydrochloride?

The 0.02% gel formulation (Valchlor) is FDA-approved for the treatment of early-stage mycosis fungoides, marking a significant milestone in its market presence[1][4].

What are the future projections for the market of mechlorethamine hydrochloride?

The market is expected to grow due to the increasing incidence of CTCL and ongoing research into new indications and formulations[4].

Sources

1. FDA NDA Review: Mechlorethamine HCL 0.02% Gel Review - Valchlor[1].
2. FDA Clinical Review: Safety Summary of Clinical Trial 2005NMMF-201-US[2].
3. JAMA Network: Mechlorethamine Hydrochloride Solutions and Ointment[3].
4. NCI Drug Dictionary: Mechlorethamine Hydrochloride[4].
5. FDA Draft Guidance: Mechlorethamine Hydrochloride Topical Gel[5].