Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002621
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Interferon Alfa in Treating Children With HIV-Related Cancer
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Alpha Interferon alphaIFN In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
Status:
COMPLETED
Status Verified Date:
2014-07
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:
RATIONALE Interferon alfa may interfere with the growth of cancer cells
PURPOSE Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia non-Hodgkins lymphoma CNS lymphoma or other solid tumors
PURPOSE Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia non-Hodgkins lymphoma CNS lymphoma or other solid tumors
Detailed Description:
OBJECTIVES
Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa
Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients
OUTLINE
Induction Patients receive interferon alfa subcutaneously SC daily on days 1-14 Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally IT combined with cytarabine IT on day 14
Maintenance Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1 Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity Patients who received IT therapy during induction receive the same IT therapy at 4 8 and 12 weeks and then every 8 weeks thereafter
Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol
PROJECTED ACCRUAL A total of 14-30 evaluable patients will be accrued for this study within 42 years
Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa
Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients
OUTLINE
Induction Patients receive interferon alfa subcutaneously SC daily on days 1-14 Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally IT combined with cytarabine IT on day 14
Maintenance Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1 Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity Patients who received IT therapy during induction receive the same IT therapy at 4 8 and 12 weeks and then every 8 weeks thereafter
Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol
PROJECTED ACCRUAL A total of 14-30 evaluable patients will be accrued for this study within 42 years
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 |
|---|---|---|---|
| CDR0000063972 | OTHER | Clinical Trialsgov | None |
| POG-9362 | OTHER | None | None |