Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000725
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase I Study of AZT and Human Interferon Alpha Recombinant Alpha-2A and Lymphoblastoid in the Treatment of AIDS-Associated 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 AZT and Human Interferon Alpha Recombinant Alpha-2A and Lymphoblastoid in the Treatment of AIDS-Associated 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 evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposis sarcoma with zidovudine AZT and two kinds of interferon alpha The two kinds are interferon alpha IFN-A and interferon alpha-2A recombinant IFN-A2A To define the pharmacokinetics of both AZT and IFN-A or IFN-A2A when given in combination to define the maximum tolerated dose of each drug in combination and to define doses to be used in Phase II trials AZT has been found to inhibit both the in vitro in test tube and cell killing effects of HIV and both interferons IFN-A and IFN-A2A have shown antiviral and antitumor effect in Kaposis sarcoma It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted
Detailed Description:
AZT has been found to inhibit both the in vitro in test tube and cell killing effects of HIV and both interferons IFN-A and IFN-A2A have shown antiviral and antitumor effect in Kaposis sarcoma It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted
Patients are randomized to receive IFN-A or IFN-A2A given by intramuscular injection and combined with AZT taken orally daily for 8 weeks Study stops when maximum tolerated dose MTD is reached Two cohorts of 4 patients enter each dose level Patients do not enter into the next dose level until all patients have completed 3 weeks of treatment AZT will escalate only if there is no unacceptable toxicity grade 2 in or 3 patients or grade 2 in any patient subsequent increases in IFN-A or IFN-A2A will be permitted but the AZT dose will remain fixed The MTD for a given IFN-A or IFN-A2A dose level is defined as grade 2 toxicity grade 3 for hemoglobin neutrophil count or SGOT in 4 of the 6 patients Patients have blood drawn every week and their general health is evaluated Pharmacokinetic studies will be done on days 1 21 and 24 Patients tolerating the combination may be continued on the same dose level for 1 year except if patient has reached complete remission for or 90 days IFN-A or IFN-A2A will decrease to 3 times a week
Patients are randomized to receive IFN-A or IFN-A2A given by intramuscular injection and combined with AZT taken orally daily for 8 weeks Study stops when maximum tolerated dose MTD is reached Two cohorts of 4 patients enter each dose level Patients do not enter into the next dose level until all patients have completed 3 weeks of treatment AZT will escalate only if there is no unacceptable toxicity grade 2 in or 3 patients or grade 2 in any patient subsequent increases in IFN-A or IFN-A2A will be permitted but the AZT dose will remain fixed The MTD for a given IFN-A or IFN-A2A dose level is defined as grade 2 toxicity grade 3 for hemoglobin neutrophil count or SGOT in 4 of the 6 patients Patients have blood drawn every week and their general health is evaluated Pharmacokinetic studies will be done on days 1 21 and 24 Patients tolerating the combination may be continued on the same dose level for 1 year except if patient has reached complete remission for or 90 days IFN-A or IFN-A2A will decrease to 3 times a week
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10989 | REGISTRY | DAIDS ES Registry Number | None |