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Last Updated: May 28, 2022

CLINICAL TRIALS PROFILE FOR TOPOTECAN HYDROCHLORIDE


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505(b)(2) Clinical Trials for Topotecan Hydrochloride

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 NCT00186888 ↗ Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma Active, not recruiting National Cancer Institute (NCI) Phase 3 2005-04-07 Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor. In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.
New Combination NCT00186888 ↗ Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma Active, not recruiting St. Jude Children's Research Hospital Phase 3 2005-04-07 Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor. In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.
New Combination NCT04661852 ↗ Cabozantinib With Topotecan-Cyclophosphamide Recruiting Dana-Farber Cancer Institute Phase 1 2020-12-23 This research study is a clinical trial of a new combination of drugs as a possible treatment for relapsed/refractory Ewing sarcoma and/or osteosarcoma. - The names of the drugs are: - Cabozantinib - Topotecan - Cyclophosphamide - The names of the non-investigational supportive care drugs are: - Filgrastim, pegfilgrastim, or a related growth factor.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Topotecan Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001333 ↗ Phase I Study of Intrathecal Topotecan Completed National Cancer Institute (NCI) Phase 1 1993-02-01 The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and 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.
NCT00002395 ↗ Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML) Completed SmithKline Beecham Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give topotecan through a vein to treat HIV-infected patients with PML, an opportunistic (AIDS-related) infection caused by a virus that infects brain tissue and causes damage to the brain and the spinal cord. Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Topotecan Hydrochloride

Condition Name

Condition Name for Topotecan Hydrochloride
Intervention Trials
Ovarian Cancer 76
Neuroblastoma 37
Small Cell Lung Cancer 34
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Condition MeSH

Condition MeSH for Topotecan Hydrochloride
Intervention Trials
Lung Neoplasms 92
Small Cell Lung Carcinoma 90
Ovarian Neoplasms 89
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Clinical Trial Locations for Topotecan Hydrochloride

Trials by Country

Trials by Country for Topotecan Hydrochloride
Location Trials
United Kingdom 71
Australia 70
Germany 68
Italy 60
Spain 56
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Trials by US State

Trials by US State for Topotecan Hydrochloride
Location Trials
California 102
New York 92
Ohio 90
Texas 90
Florida 85
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Clinical Trial Progress for Topotecan Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Topotecan Hydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 3 63
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Topotecan Hydrochloride
Clinical Trial Phase Trials
Completed 243
Recruiting 44
Terminated 44
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Clinical Trial Sponsors for Topotecan Hydrochloride

Sponsor Name

Sponsor Name for Topotecan Hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 138
GlaxoSmithKline 60
Gynecologic Oncology Group 15
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Sponsor Type

Sponsor Type for Topotecan Hydrochloride
Sponsor Trials
Other 412
Industry 215
NIH 143
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