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NCT00001379 · ClinicalTrials.gov registry record · Phase 2
Treatment and Natural History Study of Lymphomatoid Granulomatosis
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT00001379: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00001379 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 94 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001379, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study 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 etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)-rituximab (EPOCH-R) chemotherapy (each letter representing a drug). If patients have grade 1 or 2 disease, they will usually receive alpha interferon. If patients have LYG after receiving alpha interferon and/or EPOCH-R, they may receive rituximab alone or with alpha interferon. Rituximab is an antibody, binding to a specific molecule cluster of differentiation 20 (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 patient's 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.
Interventions
- PROCEDURE Tumor biopsy
- PROCEDURE Bone marrow biopsy
- BIOLOGICAL Interferon
- DRUG Rituxan and EPOCH
- BIOLOGICAL Bone marrow aspirate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 1995-05-05 |
| Est. Completion | 2025-01-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001379
The ClinicalTrials.gov registry entry for NCT00001379 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Tumor biopsy is the first listed.
NCT00001379 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001379 about?
NCT00001379 is a clinical study titled "Treatment and Natural History Study of Lymphomatoid Granulomatosis". 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 a...
What is the current status of trial NCT00001379?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 1995-05-05. Estimated completion is 2025-01-17.
What interventions are being tested in trial NCT00001379?
The interventions under investigation include: Tumor biopsy (PROCEDURE), Bone marrow biopsy (PROCEDURE), Interferon (BIOLOGICAL), Rituxan and EPOCH (DRUG), Bone marrow aspirate (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001379?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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