CLINICAL TRIALS PROFILE FOR IFOSFAMIDE; MESNA

505(b)(2) Clinical Trials for Ifosfamide; Mesna

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01884428 ↗	Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma	Unknown status	Armando Santoro, MD	Phase 1	2011-07-01	study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose

All Clinical Trials for Ifosfamide; Mesna

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001209 ↗	A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors	Completed	National Cancer Institute (NCI)	Phase 1	1986-10-01	This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.
NCT00001270 ↗	Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	1991-06-01	This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
NCT00001300 ↗	A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma	Completed	National Cancer Institute (NCI)	Phase 3	1992-06-01	Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A. Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost. Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629; and Mesna, NSC-113891. Arm II: Observation. No adjuvant chemotherapy.
NCT00001335 ↗	New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-04-01	The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF), rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term disease-free survival. Though less grave, the prognosis for cure for other high-risk patients is approximately 50%. New treatment strategies, including the identification of highly active new agents, maximizing the dose intensity of the most active standard drugs, and the development of improved methods of consolidation to eradicate microscopic residual disease, are clearly needed to improve the outcome of these patients. This protocol will address these issues by commencing with a Phase II window, for the highest risk patients, to evaluate a series of promising drugs with novel mechanisms of action. All patients will then receive 5 cycles of dose-intensive "best standard therapy" with doxorubicin (adriamycin), vincristine, and cyclophosphamide (VAdriaC). Patients at high risk of relapse will continue onto a phase I consolidation regimen consisting of three cycles of dose-escalated Melphalan, Ifosfamide, Mesna, and Etoposide (MIME). Peripheral blood stem cell transfusions (PBSCT) and recombinant human G-CSF will be used as supportive care measures to allow maximal dose-escalation of this combination regimen.

Clinical Trial Conditions for Ifosfamide; Mesna

Condition Name

Condition Name for Ifosfamide; Mesna
Intervention	Trials
Sarcoma	61
Lymphoma	56
Leukemia	21
Soft Tissue Sarcoma	20

Condition MeSH

Condition MeSH for Ifosfamide; Mesna
Intervention	Trials
Lymphoma	147
Sarcoma	122
Lymphoma, Non-Hodgkin	51
Lymphoma, B-Cell	44

Clinical Trial Locations for Ifosfamide; Mesna

Trials by Country

Trials by Country for Ifosfamide; Mesna
Location	Trials
Canada	221
Australia	97
Italy	95
United Kingdom	72
France	69

Trials by US State

Trials by US State for Ifosfamide; Mesna
Location	Trials
New York	91
California	83
Texas	82
Illinois	60
Pennsylvania	60

Clinical Trial Progress for Ifosfamide; Mesna

Clinical Trial Phase

Clinical Trial Phase for Ifosfamide; Mesna
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	89
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Ifosfamide; Mesna
Clinical Trial Phase	Trials
Completed	215
Recruiting	63
Unknown status	56

Clinical Trial Sponsors for Ifosfamide; Mesna

Sponsor Name

Sponsor Name for Ifosfamide; Mesna
Sponsor	Trials
National Cancer Institute (NCI)	133
Children's Oncology Group	26
Memorial Sloan Kettering Cancer Center	25

Sponsor Type

Sponsor Type for Ifosfamide; Mesna
Sponsor	Trials
Other	586
NIH	136
Industry	121

Clinical Trials, Market Analysis, and Projections for Ifosfamide and Mesna

Introduction

Ifosfamide and mesna are crucial components in the treatment of various cancers, particularly in the management of soft tissue sarcomas and other malignancies. This article delves into the current clinical trials, market analysis, and future projections for these drugs.

Clinical Trials and Efficacy

Ifosfamide in Cancer Treatment

Ifosfamide is an alkylating agent used in combination with other antineoplastic agents for the treatment of cancers such as germ cell testicular cancer, soft tissue sarcomas, and other malignancies. Clinical trials have consistently shown its efficacy in these settings.

• A Phase I/II study involving patients with advanced soft tissue sarcoma treated with ifosfamide and the VEGFR inhibitor sorafenib demonstrated a significant clinical benefit. The progression-free rate (PFR) at 3 and 6 months was 66% and 37%, respectively, with a median progression-free survival (PFS) of 4.8 months and overall survival of 16.2 months[4].

• Another study comparing the pharmacokinetics and clinical efficacy of intravenous versus intravenous followed by oral mesna in patients receiving ifosfamide for soft tissue sarcoma found that the intravenous/oral mesna regimen was as effective as the standard intravenous regimen in preventing hemorrhagic cystitis. This regimen also improved patient tolerance and convenience, reducing the need for hospitalizations[1].

Role of Mesna

Mesna is a critical adjunct to ifosfamide therapy, used to prevent hemorrhagic cystitis and hematuria caused by the urotoxic metabolites of ifosfamide and cyclophosphamide.

• Mesna reacts with these metabolites, such as acrolein, through a Michael addition reaction, thereby detoxifying them and protecting the bladder lining. This prophylactic use of mesna has been shown to significantly reduce the incidence of bladder toxicity[2][5].

Market Analysis

Market Size and Growth

The global mesna market is growing at a moderate pace, driven by the increasing incidence of cancer and the expanding use of chemotherapy.

• The market is expected to grow significantly from 2021 to 2028, with North America anticipated to hold the largest share during the forecast period. This growth is attributed to the evolution and rapid progress in chemotherapy practices, along with increasing FDA approvals for new therapeutics[2].

Product Types and Applications

The mesna market is segmented into oral and intravenous forms, with the oral segment dominating due to its convenience and reduced need for hospitalizations.

• Oral mesna doses must be doubled compared to intravenous doses due to bioavailability issues, but this formulation allows patients to receive treatment on an outpatient basis, reducing healthcare costs and improving patient compliance[2].

• In terms of application, retail pharmacies hold the largest share of the market, with future pharmacies expected to integrate more technology, such as telemedicine and point-of-care diagnostics[2].

Key Players

The global mesna market includes major players such as Sagent Pharmaceuticals, Athenex Pharmaceuticals, Fresenius Kabi, Baxter, Mylan, Teva Pharmaceutical, Gland Pharma Limited, Hikma Pharmaceuticals, and Jiangsu Hengrui Medicine.

• These companies are focusing on product benchmarking, SWOT analysis, and strategic market development to maintain their competitive edge in the market[2].

Market Projections

Future Trends

The increasing demand for mesna is driven by the rising incidence of cancer and the advancement in chemotherapy treatments.

• Clinical research for new treatments, such as those targeting hemorrhagic cystitis, is boosting the market's growth. The FDA's approval of new therapeutics is also expanding mesna's reach in the healthcare sector[2].

Geographic Expansion

North America is expected to continue dominating the market due to the high incidence of cancer and the rapid evolution of chemotherapy practices.

• Other regions, including Europe and Asia Pacific, are also expected to see significant growth as healthcare infrastructure improves and access to chemotherapy increases[2].

Patient Benefits and Healthcare Impact

Improved Patient Tolerance and Convenience

The use of an intravenous/oral mesna regimen has been shown to improve patient tolerance and convenience, allowing for outpatient administration of ifosfamide and reducing the need for hospitalizations. This approach also decreases the potential morbidity associated with inpatient chemotherapy administration and likely results in decreased healthcare costs[1].

Reduced Healthcare Burden

The logistical and fiscal burdens on healthcare facilities are substantial when using the standard intravenous mesna regimen. The shift to oral mesna can alleviate these burdens, making chemotherapy more accessible and manageable for both patients and healthcare providers[1].

Key Takeaways

• Clinical Efficacy: Ifosfamide and mesna combination therapy has shown significant efficacy in treating soft tissue sarcomas and other cancers, with mesna effectively preventing hemorrhagic cystitis.
• Market Growth: The global mesna market is growing due to increasing cancer incidence and advancements in chemotherapy, with North America expected to dominate the market.
• Patient Benefits: The use of oral mesna improves patient tolerance and convenience, reducing hospitalizations and healthcare costs.
• Future Trends: Continued clinical research and FDA approvals will drive market growth, with a focus on integrating technology in pharmacies to enhance patient care.

FAQs

Q: What is the primary use of mesna in cancer treatment?

A: Mesna is used to prevent hemorrhagic cystitis and hematuria caused by the urotoxic metabolites of ifosfamide and cyclophosphamide.

Q: How does the intravenous/oral mesna regimen compare to the standard intravenous regimen?

A: The intravenous/oral mesna regimen is as effective as the standard intravenous regimen in preventing hemorrhagic cystitis and offers improved patient tolerance and convenience, reducing the need for hospitalizations.

Q: What are the key drivers of the global mesna market?

A: The key drivers include the increasing incidence of cancer, advancements in chemotherapy practices, and FDA approvals for new therapeutics.

Q: Which region is expected to dominate the mesna market in the forecast period?

A: North America is expected to dominate the market due to the high incidence of cancer and rapid advancements in chemotherapy practices.

Q: What are the benefits of using oral mesna compared to intravenous mesna?

A: Oral mesna allows for outpatient administration, reduces hospitalizations, and decreases healthcare costs while maintaining the same level of efficacy as intravenous mesna.

Sources

1. Crossover Randomized Comparison of Intravenous versus Intravenous/Oral Mesna in Patients Receiving Ifosfamide for Soft Tissue Sarcoma. Clinical Cancer Research, 9(16), 5829.
2. Mesna (Mesnex) Market Size, Share, Trends, Opportunities & Forecast. Verified Market Research.
3. Protocol for Research Purposes Only. ClinicalTrials.gov.
4. Phase II Trial of Ifosfamide in Combination with the VEGFR Inhibitor Sorafenib. PubMed.
5. Ifosfamide and Mesna Injection: Package Insert / Prescribing Info. Drugs.com.