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NCT00101101 · ClinicalTrials.gov registry record · Phase 2
Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT00101101 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 43 participants.
The verdict
NCT00101101, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination chemotherapy may be a more effective treatment for mantle cell lymphoma. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2 after combination chemotherapy works in treating patients with relapsed or de novo stage II, stage III, or stage IV mantle cell lymphoma.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2004-07 |
| Est. Completion | 2021-06-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00101101
The ClinicalTrials.gov registry entry for NCT00101101 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00101101 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00101101 about?
NCT00101101 is a clinical study titled "Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma". RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a stronger immune response and ...
What is the current status of trial NCT00101101?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2004-07. Estimated completion is 2021-06-14.
What interventions are being tested in trial NCT00101101?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT00101101?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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