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NCT00005780 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma and Lymphoma, Mantle-Cell, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00005780 is a Phase 2 study of Mantle Cell Lymphoma and Lymphoma, Mantle-Cell that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00005780, a Phase 2 study of Mantle Cell Lymphoma and Lymphoma, Mantle-Cell, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and effectiveness of an experimental cancer vaccine for mantle cell lymphoma a form of cancer of the white blood cells called lymphocytes. Although standard treatments for lymphoma may achieve disease remission, none provides a cure. Patients with mantle cell lymphoma 18 years and older who have not been treated previously with chemotherapy may participate in this study. Candidates will be screened for eligibility with a medical history and physical examination. Other tests that may be required include blood and urine tests; lung function studies; imaging tests such as magnetic resonance imaging, computed tomography and X-rays; and biopsy (surgical removal of a small tissue sample) of tumor, bone marrow, or other tissue. Patients enrolled in the study will begin treatment with chemotherapy designed to reduce disease to a minimum that is, to achieve remission or shrink the tumor as much as possible. Chemotherapy will be administered on an outpatient basis over a period of around 12 to 18 weeks in 3-week cycles as follows: prednisone by mouth on days 1 through 5; etoposide, doxorubicin and vincristine intravenously through (a vein) on days 1 through 5; and cyclophosphamide intravenously on day 5. Starting day 6, patients receive no chemotherapy for 16 days. In addition, an antibody called rituximab, which attaches to lymphoma cells and may increase the effectiveness of the chemotherapy, will be given on day 1 of the cycle. Patients will also receive a protein called granulocyte colony-stimulating factor (G-CSF) starting day 6 of the cycle and continuing until the white blood cell count recovers or until day 19. G-CSF is naturally produced by bone marrow and may boost the immune system. The chemotherapy drugs and rituximab are infused through a vein by means of a lightweight portable pump, which patients are taught how to use. Patients are also how taught how to give themselves G-CSF injections under the skin, similar to insulin in
Conditions Studied
Interventions
- BIOLOGICAL GM-CSF
- DRUG EPOCH-R
- BIOLOGICAL Idiotype vaccine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2000-06-01 |
| Est. Completion | 2021-06-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005780
The ClinicalTrials.gov registry entry for NCT00005780 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (75% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which GM-CSF is the first listed.
NCT00005780 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00005780 about?
NCT00005780 is a clinical study titled "Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma". This study will evaluate the safety and effectiveness of an experimental cancer vaccine for mantle cell lymphoma a form of cancer of the white blood cells called lymphocytes. Although standard treatments for lymphoma may achieve disease remission, none provides a cure. Patients with mantle cell lym...
What is the current status of trial NCT00005780?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2000-06-01. Estimated completion is 2021-06-16.
What conditions does trial NCT00005780 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Lymphoma, Mantle-Cell.
What interventions are being tested in trial NCT00005780?
The interventions under investigation include: GM-CSF (BIOLOGICAL), EPOCH-R (DRUG), Idiotype vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00005780?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00005780 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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