Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000681
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase I Study of the Combination of Recombinant GM-CSF AZT and Chemotherapy ABV Adriamycin Bleomycin Vincristine in AIDS and Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of the Combination of Recombinant GM-CSF AZT and Chemotherapy ABV Adriamycin Bleomycin Vincristine in AIDS and Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the safety as well as the most effective dose of sargramostim GM-CSF granulocyte-macrophage colony stimulating factor that will prevent the side effects caused by the combined use of zidovudine AZT and various doses of cancer-fighting drugs doxorubicin bleomycin and vincristine in AIDS patients with Kaposis sarcoma KS
Patients included in this study have KS which is a type of cancer that occurs in nearly 20 percent of patients with AIDS AIDS patients with extensive KS require treatment with effective cytotoxic anti-cancer agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated the combination of these agents is expected to result in complications such as granulocytopenia very low granulocyte counts Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression This may improve survival Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells early blood cells are responsive to GM-CSF
Patients included in this study have KS which is a type of cancer that occurs in nearly 20 percent of patients with AIDS AIDS patients with extensive KS require treatment with effective cytotoxic anti-cancer agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated the combination of these agents is expected to result in complications such as granulocytopenia very low granulocyte counts Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression This may improve survival Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells early blood cells are responsive to GM-CSF
Detailed Description:
Patients included in this study have KS which is a type of cancer that occurs in nearly 20 percent of patients with AIDS AIDS patients with extensive KS require treatment with effective cytotoxic anti-cancer agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated the combination of these agents is expected to result in complications such as granulocytopenia very low granulocyte counts Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression This may improve survival Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells early blood cells are responsive to GM-CSF
AMENDED 910222 Due to continued concerns about GM-CSF toxicities seen in the 5 mcgkg GM-CSF with 20 mgm2 adriamycinBVAZT cohort the GM-CSF dose in this study has been reduced while the adriamycin dose escalation will continue
AMENDED 900430 Dosages for AZT and GM-CSF changed to reflect ongoing results Original design Patients receive the combination of AZT antineoplastic chemotherapy and GM-CSF in groups of three patients each The first group receives baseline doses and if the treatment is well tolerated the subsequent groups of patients receive higher doses of the chemotherapy in which the dose of doxorubicin is increased while bleomycin vincristine and AZT doses remain fixed throughout the study The dose of all drugs remains fixed for a given patient The anticancer drugs are given intravenously every 2 weeks AZT is given every 4 hours by mouth GM-CSF is self-injected subcutaneously every day from day 2 - day 12 of each treatment cycle Patients repeat the chemotherapy every 2 weeks for a maximum of seven cycles with AZT being given continuously When the maximum tolerated dose MTD of chemotherapy combined with GM-CSF is determined the next phase of the study begins Again the dose of chemotherapy is increased in groups of patients but the every-day dose of GM-CSF is increased Again these chemotherapy cycles are repeated every 2 weeks up to a maximum of seven cycles Patients receive physician examination and laboratory tests every week during the study and again at 4 weeks after the study AMENDED Dosages for AZT and GM-CSF have been changed to reflect ongoing results
AMENDED 910222 Due to continued concerns about GM-CSF toxicities seen in the 5 mcgkg GM-CSF with 20 mgm2 adriamycinBVAZT cohort the GM-CSF dose in this study has been reduced while the adriamycin dose escalation will continue
AMENDED 900430 Dosages for AZT and GM-CSF changed to reflect ongoing results Original design Patients receive the combination of AZT antineoplastic chemotherapy and GM-CSF in groups of three patients each The first group receives baseline doses and if the treatment is well tolerated the subsequent groups of patients receive higher doses of the chemotherapy in which the dose of doxorubicin is increased while bleomycin vincristine and AZT doses remain fixed throughout the study The dose of all drugs remains fixed for a given patient The anticancer drugs are given intravenously every 2 weeks AZT is given every 4 hours by mouth GM-CSF is self-injected subcutaneously every day from day 2 - day 12 of each treatment cycle Patients repeat the chemotherapy every 2 weeks for a maximum of seven cycles with AZT being given continuously When the maximum tolerated dose MTD of chemotherapy combined with GM-CSF is determined the next phase of the study begins Again the dose of chemotherapy is increased in groups of patients but the every-day dose of GM-CSF is increased Again these chemotherapy cycles are repeated every 2 weeks up to a maximum of seven cycles Patients receive physician examination and laboratory tests every week during the study and again at 4 weeks after the study AMENDED Dosages for AZT and GM-CSF have been changed to reflect ongoing results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11069 | REGISTRY | DAIDS ES Registry Number | None |