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Last Updated: December 13, 2024

CLINICAL TRIALS PROFILE FOR DACARBAZINE


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505(b)(2) Clinical Trials for Dacarbazine

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 NCT05068453 ↗ Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis Not yet recruiting Beijing Cancer Hospital Phase 1 2021-10-01 Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.
New Combination NCT05070221 ↗ Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis Not yet recruiting Beijing Cancer Hospital Phase 1 2021-10-01 Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dacarbazine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000626 ↗ Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease Completed Amgen Phase 2 1969-12-31 Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00000626 ↗ Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00002561 ↗ Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease Completed Eastern Cooperative Oncology Group Phase 3 1994-01-25 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 drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.
NCT00002561 ↗ Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease Completed NCIC Clinical Trials Group Phase 3 1994-01-25 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 drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.
NCT00002669 ↗ Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 2 1995-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.
NCT00002791 ↗ Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma Completed Eastern Cooperative Oncology Group Phase 2 1997-02-01 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 radiation therapy with more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dacarbazine

Condition Name

Condition Name for Dacarbazine
Intervention Trials
Melanoma 36
Hodgkin Lymphoma 28
Lymphoma 21
Malignant Melanoma 13
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Condition MeSH

Condition MeSH for Dacarbazine
Intervention Trials
Melanoma 106
Hodgkin Disease 85
Lymphoma 79
Sarcoma 17
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Clinical Trial Locations for Dacarbazine

Trials by Country

Trials by Country for Dacarbazine
Location Trials
Canada 133
Germany 100
United Kingdom 99
Italy 98
Australia 81
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Trials by US State

Trials by US State for Dacarbazine
Location Trials
California 68
New York 56
Texas 56
Illinois 47
Pennsylvania 47
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Clinical Trial Progress for Dacarbazine

Clinical Trial Phase

Clinical Trial Phase for Dacarbazine
Clinical Trial Phase Trials
Phase 4 4
Phase 3 62
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Dacarbazine
Clinical Trial Phase Trials
Completed 105
Recruiting 44
Active, not recruiting 32
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Clinical Trial Sponsors for Dacarbazine

Sponsor Name

Sponsor Name for Dacarbazine
Sponsor Trials
National Cancer Institute (NCI) 33
Bristol-Myers Squibb 15
Seagen Inc. 12
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Sponsor Type

Sponsor Type for Dacarbazine
Sponsor Trials
Other 242
Industry 154
NIH 35
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