Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001379
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
1999-11-03
Brief Title:
Treatment and Natural History Study of Lymphomatoid Granulomatosis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment and Natural History Study of Lymphomatoid Granulomatosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09-26
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:
This study will evaluate the response and long-term effects of alpha-interferon in patients with lymphomatoid granulomatosis LYG The disease causes proliferation of destructive cells involving the lungs skin kidneys and central nervous system
Patients ages 12 and older who have LYG and who are not pregnant or breast feeding may be eligible for this study Alpha interferon or chemotherapy or both will be used Alpha interferon is a protein the body naturally produces If patients have grade 3 disease they will usually receive EPOCH-rituximab EPOCH-R chemotherapy each letter representing a drug If patients have grade 1 or 2 disease the will usually receive alpha interferon If patients have LYG after receiving alpha interferon andor EPOCH-R they may receive rituximab alone or with alpha interferon Rituximab is an antibody binding to a specific molecule CD20 present on most B-cell lymphomas Doses of several drugs in EPOCH-R may be increased if patients tolerated them in the previous cycle If patients respond to EPOCH-R but still have low grade LYG they may receive alpha interferon Researchers will also try to obtain a biopsy of patients lesions to help in understanding the disease
Patients self-administer alpha interferon by injection under the skin three times weekly They will visit the clinic every 2 to 12 weeks for follow-up Patients will receive alpha interferon for 1 year after LYG goes away depending on response EPOCH-R has these drugs rituximab by vein on Day 1 prednisone by mouth on Days 1 to 5 etoposide doxorubicin and vincristine as a continuous intravenous infusion on Days 1 to 5 and cyclophosphamide by intravenous injection over 1 hour on Day 5 Each cycle lasts 3 weeks 5 days of chemotherapy and 16 days of no chemotherapy Etoposide doxorubicin and vincristine are infused through a small pump worn by patients The drugs are given over 5 days through a central intravenous catheter There are two cycles of EPOCH-R beyond a maximum response with six cycles minimum To reduce harm to bone marrow patients receive granulocyte colony stimulating factor G-CSF self-administered by injection under the skin daily for approximately 10 days between chemotherapy cycles If at the end of therapy patients have a complete response treatment will stop If there is residual low grade disease patients may receive alpha interferon Alpha interferon can have flu-like side effects of headache fever chills and body aches EPOCH-R drugs can cause gastrointestinal problems hair loss and weakness G-CSF can cause bone pain body aches and hair thinning Chemotherapy can cause some patients to develop leukemia
This study may or may not have a direct benefit for participants It is not certain whether the new therapy will help decrease tumors However knowledge gained may improve the understanding of and treatment for LYG
Patients ages 12 and older who have LYG and who are not pregnant or breast feeding may be eligible for this study Alpha interferon or chemotherapy or both will be used Alpha interferon is a protein the body naturally produces If patients have grade 3 disease they will usually receive EPOCH-rituximab EPOCH-R chemotherapy each letter representing a drug If patients have grade 1 or 2 disease the will usually receive alpha interferon If patients have LYG after receiving alpha interferon andor EPOCH-R they may receive rituximab alone or with alpha interferon Rituximab is an antibody binding to a specific molecule CD20 present on most B-cell lymphomas Doses of several drugs in EPOCH-R may be increased if patients tolerated them in the previous cycle If patients respond to EPOCH-R but still have low grade LYG they may receive alpha interferon Researchers will also try to obtain a biopsy of patients lesions to help in understanding the disease
Patients self-administer alpha interferon by injection under the skin three times weekly They will visit the clinic every 2 to 12 weeks for follow-up Patients will receive alpha interferon for 1 year after LYG goes away depending on response EPOCH-R has these drugs rituximab by vein on Day 1 prednisone by mouth on Days 1 to 5 etoposide doxorubicin and vincristine as a continuous intravenous infusion on Days 1 to 5 and cyclophosphamide by intravenous injection over 1 hour on Day 5 Each cycle lasts 3 weeks 5 days of chemotherapy and 16 days of no chemotherapy Etoposide doxorubicin and vincristine are infused through a small pump worn by patients The drugs are given over 5 days through a central intravenous catheter There are two cycles of EPOCH-R beyond a maximum response with six cycles minimum To reduce harm to bone marrow patients receive granulocyte colony stimulating factor G-CSF self-administered by injection under the skin daily for approximately 10 days between chemotherapy cycles If at the end of therapy patients have a complete response treatment will stop If there is residual low grade disease patients may receive alpha interferon Alpha interferon can have flu-like side effects of headache fever chills and body aches EPOCH-R drugs can cause gastrointestinal problems hair loss and weakness G-CSF can cause bone pain body aches and hair thinning Chemotherapy can cause some patients to develop leukemia
This study may or may not have a direct benefit for participants It is not certain whether the new therapy will help decrease tumors However knowledge gained may improve the understanding of and treatment for LYG
Detailed Description:
BACKGROUND
Lymphomatoid granulomatosis LYG is an angiocentric destructive proliferation of lymphoid cells predominantly involving the lungs skin kidneys and central nervous system
It is divided into three grades depending on the degree of necrosis and cellular atypia The grades of disease are histologically-based and do not necessarily correlate with clinical outcome However like other EBV related LPDs LYG can transform into an aggressive large B-cell lymphoma which would be included within the grade 3 category It is important to note that not all grade 3 lesions are a large B-cell lymphoma
Current evidence shows that LYG is a disease of B cells
OBJECTIVES
To determine the response and long-term efficacy of alpha-Interferon in patients with lymphomatoid granulomatosis LYG
To determine the response and long-term efficacy of dose-adjusted DA-EPOCH-R chemotherapy in patients with grade 3 LYG or in patients who have failed interferon
ELIGIBILITY
Patients must have a tissue diagnosis of grade 1 2 andor 3 LYG or a diagnosis consistent with LYG confirmed by the Laboratory of Pathology NCI
Patients with any stage of disease will be eligible
Previously untreated and treated patients are eligible
Patients age 12 or older will be eligible
DESIGN
Interferon is used as initial treatment in patients with grades 1 and 2 LYG Patients will receive interferon for one year past CR
Patients who progress after or during interferon and patients with grade 3 LYG will receive aggressive combination chemotherapy with DA-EPOCH-R rituximab etoposide doxorubicin vincristine cyclophosphamide and prednisone
Patients who fail one treatment approach may be crossed over to the other
A total of 105 patients will be enrolled at this single institution
Lymphomatoid granulomatosis LYG is an angiocentric destructive proliferation of lymphoid cells predominantly involving the lungs skin kidneys and central nervous system
It is divided into three grades depending on the degree of necrosis and cellular atypia The grades of disease are histologically-based and do not necessarily correlate with clinical outcome However like other EBV related LPDs LYG can transform into an aggressive large B-cell lymphoma which would be included within the grade 3 category It is important to note that not all grade 3 lesions are a large B-cell lymphoma
Current evidence shows that LYG is a disease of B cells
OBJECTIVES
To determine the response and long-term efficacy of alpha-Interferon in patients with lymphomatoid granulomatosis LYG
To determine the response and long-term efficacy of dose-adjusted DA-EPOCH-R chemotherapy in patients with grade 3 LYG or in patients who have failed interferon
ELIGIBILITY
Patients must have a tissue diagnosis of grade 1 2 andor 3 LYG or a diagnosis consistent with LYG confirmed by the Laboratory of Pathology NCI
Patients with any stage of disease will be eligible
Previously untreated and treated patients are eligible
Patients age 12 or older will be eligible
DESIGN
Interferon is used as initial treatment in patients with grades 1 and 2 LYG Patients will receive interferon for one year past CR
Patients who progress after or during interferon and patients with grade 3 LYG will receive aggressive combination chemotherapy with DA-EPOCH-R rituximab etoposide doxorubicin vincristine cyclophosphamide and prednisone
Patients who fail one treatment approach may be crossed over to the other
A total of 105 patients will be enrolled at this single institution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 94-C-0074 | None | None | None |