CLINICAL TRIALS PROFILE FOR IFOSFAMIDE

505(b)(2) Clinical Trials for ifosfamide

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT00002494 ↗	Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1992-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
NCT00002494 ↗	Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia	Completed	Alliance for Clinical Trials in Oncology	Phase 2	1992-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
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.
NCT00002466 ↗	Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	1990-05-01	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 or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.
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.

Clinical Trial Conditions for ifosfamide

Condition Name

Condition Name for ifosfamide
Intervention	Trials
Sarcoma	61
Lymphoma	56
Leukemia	21
Soft Tissue Sarcoma	20

Condition MeSH

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

Clinical Trial Locations for ifosfamide

Trials by Country

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

Trials by US State

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−

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

Clinical Trial Progress for ifosfamide

Clinical Trial Phase

Clinical Trial Phase for ifosfamide
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	89
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for ifosfamide
Clinical Trial Phase	Trials
Completed	215
Recruiting	63
Unknown status	56

Clinical Trial Sponsors for ifosfamide

Sponsor Name

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

Sponsor Type

Sponsor Type for ifosfamide
Sponsor	Trials
Other	586
NIH	136
Industry	121

Ifosfamide: Clinical Trials, Market Analysis, and Projections

Introduction to Ifosfamide

Ifosfamide is a chemotherapy drug used to treat various types of cancer, including testicular cancer, ovarian cancer, and certain types of sarcomas. Here, we will delve into recent clinical trials, market analysis, and future projections for ifosfamide.

Clinical Trials Update

Ewing Sarcoma

A significant clinical trial update comes from the rEECur study, which compared chemotherapy regimens for recurrent or treatment-resistant Ewing sarcoma. This trial found that patients who received high doses of ifosfamide lived a median of 15.4 months, compared to 10.5 months for those who received topotecan plus cyclophosphamide. This indicates that ifosfamide may be a preferred treatment option for some patients with Ewing sarcoma[3].

High-Grade Osteosarcoma

The OLIE phase II trial evaluated the efficacy and safety of lenvatinib combined with ifosfamide and etoposide in children and young adults with high-grade osteosarcoma. The trial showed that the combination of lenvatinib with ifosfamide and etoposide (LEN-IE) had a median progression-free survival (PFS) of 6.5 months, compared to 5.5 months for ifosfamide and etoposide (IE) alone. Although the difference did not reach statistical significance, it suggests potential benefits of combining ifosfamide with other agents[1].

Market Analysis

Current Market Size and Growth

The market for germ cell tumors, which includes testicular cancer and ovarian cancer, is significant and growing. In 2024, the germ cell tumor market was valued at USD 13.87 billion and is projected to exceed USD 22.52 billion by 2037, with a compound annual growth rate (CAGR) of over 3.8% during the forecast period[2].

Route of Administration

In the germ cell tumor market, the parenteral segment is expected to hold the largest revenue share by 2037. Parenteral therapies, which include intravenous administration of drugs like ifosfamide, are becoming more accepted due to advances in drug delivery systems that make them more convenient and tolerable for patients[2].

Treatment Type

Chemotherapy remains the gold standard for treating germ cell tumors, and ifosfamide is a key component of many chemotherapy regimens. The use of ifosfamide in combination with other drugs, such as etoposide and cisplatin, is common and contributes significantly to the market growth[2].

Regional Market Projections

North America

The North American market is expected to hold the largest revenue share in the germ cell tumor market, driven by extensive research and development, increased cancer awareness, and expanded healthcare infrastructure. The use of combination therapies, including ifosfamide, in prestigious cancer institutes in the U.S. further fuels this growth[2].

Asia Pacific

The Asia Pacific region is also expected to see significant growth in the germ cell tumor market. This is due to increased diagnosis and treatment of diseases, government initiatives to improve public health, and the development of novel treatment options. For instance, India's National Health Policy aims to increase government expenditure on public health care, which will contribute to market growth[2].

Future Projections

Increasing Prevalence and Awareness

The growth of the germ cell tumor market, and consequently the demand for ifosfamide, is driven by the increasing prevalence of germ cell cancers. Enhanced awareness and diagnosis programs lead to early detection and treatment, which in turn increase the opportunities for using ifosfamide and other chemotherapy drugs[2].

Innovative Therapies

Current and future clinical trials are focusing on molecular-driven and innovative designs, which may lead to more personalized medicine approaches. While these trials may introduce new treatment options, ifosfamide is likely to remain a cornerstone in chemotherapy regimens due to its established efficacy and safety profile[4].

Economic Factors

The market for ifosfamide is also influenced by economic factors, including government support for healthcare and the availability of advanced drug delivery systems. As healthcare infrastructure improves globally, the demand for effective and tolerable chemotherapy drugs like ifosfamide is expected to rise[2].

Key Takeaways

• Clinical Trials: Ifosfamide has shown promising results in clinical trials for Ewing sarcoma and high-grade osteosarcoma, indicating its potential as a preferred treatment option.
• Market Growth: The germ cell tumor market, which includes ifosfamide, is projected to grow significantly, driven by increasing prevalence, awareness, and advances in drug delivery systems.
• Regional Projections: North America and the Asia Pacific region are expected to be key markets for ifosfamide due to extensive R&D, increased cancer awareness, and government health initiatives.
• Future Trends: Ifosfamide is likely to remain a crucial component of chemotherapy regimens, with ongoing clinical trials and innovative therapies potentially enhancing its use.

FAQs

What is ifosfamide used for?

Ifosfamide is a chemotherapy drug used to treat various types of cancer, including testicular cancer, ovarian cancer, Ewing sarcoma, and high-grade osteosarcoma.

What are the recent clinical trial findings for ifosfamide?

Recent trials have shown that ifosfamide can improve survival in patients with Ewing sarcoma and may offer benefits when combined with other agents in treating high-grade osteosarcoma.

What is the projected market size for the germ cell tumor market by 2037?

The germ cell tumor market is projected to exceed USD 22.52 billion by 2037, with a CAGR of over 3.8% during the forecast period.

Which region is expected to hold the largest revenue share in the germ cell tumor market?

The North American market is expected to hold the largest revenue share in the germ cell tumor market.

How does the route of administration impact the market for ifosfamide?

The parenteral segment, which includes intravenous administration of ifosfamide, is expected to hold the largest revenue share due to advances in drug delivery systems that make these therapies more convenient and tolerable.

Sources

1. JAMA Oncology: "Lenvatinib Plus Ifosfamide and Etoposide in Children and Young Adults With High-Grade Osteosarcoma: The OLIE Phase 2 Randomized Clinical Trial"[1].
2. Research Nester: "Germ Cell Tumor Market Size - Growth Forecasts 2037"[2].
3. National Cancer Institute: "Trial Results May Help Inform Treatments for Ewing Sarcoma"[3].
4. Current Obstetrics and Gynecology Reports: "Update on new treatments for rare ovarian tumours"[4].