CLINICAL TRIALS PROFILE FOR TEPADINA

All Clinical Trials for Tepadina

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00554788 ↗	Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-02-04	This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient?s blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.
NCT00554788 ↗	Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma	Active, not recruiting	Children's Oncology Group	Phase 3	2008-02-04	This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient?s blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.
NCT00567567 ↗	Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-11-05	This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
NCT00567567 ↗	Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma	Active, not recruiting	Children's Oncology Group	Phase 3	2007-11-05	This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.

Clinical Trial Conditions for Tepadina

Condition Name

Condition Name for Tepadina
Intervention	Trials
Acute Myeloid Leukemia	9
Acute Lymphoblastic Leukemia	8
Myelodysplastic Syndrome	7
Acute Biphenotypic Leukemia	5

Condition MeSH

Condition MeSH for Tepadina
Intervention	Trials
Leukemia	14
Myelodysplastic Syndromes	13
Preleukemia	12
Leukemia, Myeloid	11

Clinical Trial Locations for Tepadina

Trials by Country

Trials by Country for Tepadina
Location	Trials
United States	248
Canada	17
Australia	9
New Zealand	2
Italy	2

Trials by US State

Trials by US State for Tepadina
Location	Trials
Washington	13
California	12
Texas	12
New York	11
Pennsylvania	11

Clinical Trial Progress for Tepadina

Clinical Trial Phase

Clinical Trial Phase for Tepadina
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	19
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Tepadina
Clinical Trial Phase	Trials
Recruiting	14
Active, not recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for Tepadina

Sponsor Name

Sponsor Name for Tepadina
Sponsor	Trials
National Cancer Institute (NCI)	19
Fred Hutchinson Cancer Research Center	8
Children's Oncology Group	6

Sponsor Type

Sponsor Type for Tepadina
Sponsor	Trials
Other	32
NIH	24
Industry	5

TEPADINA: Clinical Trials, Market Analysis, and Projections

Introduction

TEPADINA, also known as thiotepa, is an alkylating agent that has been in use for over 50 years. It is utilized in various medical applications, including the prevention of graft rejection in stem cell transplantation and the treatment of several types of cancers. Here, we will delve into the clinical trials, market analysis, and projections for TEPADINA.

Clinical Trials and Efficacy

Graft Rejection Prevention

TEPADINA has been extensively studied for its role in reducing the risk of graft rejection in allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT), particularly in pediatric patients with class 3 beta-thalassemia. The FDA approved TEPADINA for this indication based on the results of Protocol 26M, a single-arm trial that demonstrated a significant reduction in graft rejection rates. None of the 25 patients treated with TEPADINA in this trial experienced primary or late graft rejection, compared to a 25.5% rejection rate in a control group of 51 patients[1][3].

Cancer Treatment

TEPADINA is also indicated for the treatment of adenocarcinoma of the breast or ovary, controlling intracavitary effusions secondary to neoplastic diseases, and treating superficial papillary carcinoma of the urinary bladder. Clinical trials have shown its efficacy in these areas, although the drug's use is often associated with significant side effects such as myelosuppression and potential carcinogenicity[2][3].

Safety and Adverse Reactions

Myelosuppression

One of the most significant adverse reactions associated with TEPADINA is myelosuppression, which can lead to severe marrow suppression, infections, anemia, and thrombocytopenia. This necessitates careful monitoring of hematologic parameters and supportive care to manage these complications[3][4].

Other Adverse Reactions

Other notable adverse reactions include hypersensitivity, cutaneous toxicity, hepatic veno-occlusive disease, central nervous system toxicity, and carcinogenicity. The drug is also teratogenic and can cause fetal harm, necessitating strict contraception measures for patients undergoing treatment[3][4].

Market Analysis

Current Market Position

TEPADINA, under the brand name Tepadina, has received regulatory approvals in several regions, including the United States and the European Union. The European Medicines Agency (EMA) has authorized Thiotepa Riemser, a comparable product, for use in the EU, indicating a strong market presence for thiotepa-based treatments[5].

Market Demand

The demand for TEPADINA is driven by the need for effective conditioning regimens in HSCT and the treatment of specific malignancies. The increasing incidence of cancers such as breast, ovarian, and bladder cancers, along with the growing number of HSCT procedures, contributes to the steady demand for this drug.

Competitive Landscape

The market for alkylating agents is competitive, with several other drugs available for similar indications. However, TEPADINA's unique profile and FDA approvals for specific indications, such as reducing graft rejection in HSCT for pediatric patients with class 3 beta-thalassemia, provide it with a niche market position.

Market Projections

Growth Potential

Given the increasing prevalence of cancers and the advancements in HSCT procedures, the market for TEPADINA is expected to grow. The drug's efficacy in reducing graft rejection and its role in treating various malignancies position it for continued demand.

Regulatory Environment

Regulatory approvals and designations, such as Orphan Drug and Fast Track Designations, have facilitated the development and marketing of TEPADINA. Continued regulatory support and monitoring by agencies like the FDA and EMA will be crucial for its market growth.

Economic Factors

The cost-effectiveness of TEPADINA compared to other conditioning regimens and cancer treatments will influence its market share. The need for supportive care and management of adverse reactions may impact the overall cost of treatment, but the drug's efficacy and safety profile are expected to maintain its market viability.

Key Takeaways

• Clinical Efficacy: TEPADINA has demonstrated significant efficacy in reducing graft rejection in HSCT and treating various cancers.
• Safety Profile: The drug is associated with significant adverse reactions, including myelosuppression and potential carcinogenicity.
• Market Position: TEPADINA holds a niche market position due to its unique indications and regulatory approvals.
• Growth Potential: The market for TEPADINA is expected to grow driven by increasing cancer incidence and advancements in HSCT.
• Regulatory Support: Continued regulatory approvals and monitoring are crucial for its market growth.

FAQs

What is TEPADINA used for?

TEPADINA is used to reduce the risk of graft rejection in allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) and to treat various malignancies, including adenocarcinoma of the breast or ovary, malignant effusions, and superficial papillary carcinoma of the urinary bladder[3].

What are the common adverse reactions associated with TEPADINA?

Common adverse reactions include myelosuppression, hypersensitivity, cutaneous toxicity, hepatic veno-occlusive disease, central nervous system toxicity, and carcinogenicity[3][4].

Is TEPADINA approved for use in pediatric patients?

Yes, TEPADINA is approved for reducing the risk of graft rejection in HSCT for pediatric patients with class 3 beta-thalassemia[1][3].

What is the recommended dosage of TEPADINA for HSCT?

The recommended dose of TEPADINA for HSCT is two administrations of 5 mg/kg given intravenously approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide[3].

Can TEPADINA cause secondary malignancies?

Yes, like many alkylating agents, TEPADINA has been reported to be carcinogenic and can increase the risk of secondary malignancies[3][4].

Is TEPADINA safe during pregnancy?

No, TEPADINA can cause fetal harm and is contraindicated in pregnant women. Effective contraception is advised for both females and males of reproductive potential during and after treatment[3][4].

Sources

1. FDA Cross-Discipline Team Leader Review: "Cross-Discipline Team Leader Review NDA # NDA 208264 (Original)"[1].
2. DrugBank Online: "Thiotepa: Uses, Interactions, Mechanism of Action"[2].
3. FDA Label: "TEPADINA - thiotepa injection, powder, lyophilized, for solution"[3].
4. FDA Label (Corrected): "TEPADINA - thiotepa injection, powder, lyophilized, for solution"[4].
5. European Medicines Agency: "Thiotepa Riemser"[5].