Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001438
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children With Immunodeficiency Syndromes
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children With Immunodeficiency Syndromes
Status:
COMPLETED
Status Verified Date:
2000-01
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:
Patients with congenital or acquired immunodeficiencies are at an increased risk to develop polyclonal or oligoclonal lymphoid malignancies Some develop a lymphoproliferative disorder that can follow a clinically aggressive course and may represent a pre-malignant lesion Although most of these lymphoproliferative disorders are of B-cell origin T-cell or non-B-non-T-cell processes have also been observed The pathogenesis is only partially understood
In the case of pre-malignant conditions it is often difficult to know when and whether a therapeutic intervention is necessary and a careful consideration of potential treatment-associated morbidity is indicated Therapies have ranged from influencing the possible infectious etiology by treating with acyclovir decreasing the amount of immunosuppression in transplant patients to the use of immunomodulatory agents including interferons and interleukins Recent data have indicated that the use of differentiating agents such as the retinoids might offer yet another treatment option In the current study we will try to get a better understanding of the pathogenesis and natural course of lymphoproliferative disorders in immunodeficient children
The study will have two parts an initial observation period to obtain information on the natural course of these disorders and then a six month treatment period with the combination of a differentiating agent 13-cis-retinoic acid was used until all-trans-retinoic acid became available on 796 with an immunomodulatory agent interferon-alpha2a IFN-alpha2a
In the case of pre-malignant conditions it is often difficult to know when and whether a therapeutic intervention is necessary and a careful consideration of potential treatment-associated morbidity is indicated Therapies have ranged from influencing the possible infectious etiology by treating with acyclovir decreasing the amount of immunosuppression in transplant patients to the use of immunomodulatory agents including interferons and interleukins Recent data have indicated that the use of differentiating agents such as the retinoids might offer yet another treatment option In the current study we will try to get a better understanding of the pathogenesis and natural course of lymphoproliferative disorders in immunodeficient children
The study will have two parts an initial observation period to obtain information on the natural course of these disorders and then a six month treatment period with the combination of a differentiating agent 13-cis-retinoic acid was used until all-trans-retinoic acid became available on 796 with an immunomodulatory agent interferon-alpha2a IFN-alpha2a
Detailed Description:
Patients with congenital or acquired immunodeficiencies are at an increased risk to develop polyclonal or oligoclonal lymphoid malignancies Some develop a lymphoproliferative disorder that can follow a clinically aggressive course and may represent a pre-malignant lesion Although most of these lymphoproliferative disorders are of B-cell origin T-cell or non-B-non-T-cell processes have also been observed The pathogenesis is only partially understood The Epstein-Barr virus EBV is thought to play an important role but the human herpes virus type 6 HHV-6 has been implicated as well An imbalance in the expression of several cytokines is observed and it is currently not clear whether this sustains the aberrant proliferation or is a result thereof In the case of pre-malignant conditions it is often difficult to know when and whether a therapeutic intervention is necessary and a careful consideration of potential treatment-associated morbidity is indicated Therapies have ranged from influencing the possible infectious etiology by treating with acyclovir decreasing the amount of immunosuppression in transplant patients to the use of immunomodulatory agents including interferons and interleukins Recent data have indicated that the use of differentiating agents such as the retinoids might offer yet another treatment option In the current study we will try to get a better understanding of the pathogenesis and natural course of lymphoproliferative disorders in immunodeficient children The study will mainly be open to children infected with the human immunodeficiency virus but patients who develop a lymphoproliferative disorder post-transplant or as part of another immunodeficiency state may also be enrolled The study will have two parts an initial observation period to obtain information on the natural course of these disorders and then a six month treatment period with the combination of a differentiating agent 13-cis-retinoic acid was used until all-trans-retinoic acid became available on 796 with an immunomodulatory agent interferon-alpha2a IFN-alpha2a
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 |
|---|---|---|---|
| 95-C-0144 | None | None | None |