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NCT00001507 · ClinicalTrials.gov registry record · Phase 1
Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer
A Phase 1 study of Neoplasm Metastasis and Breast Neoplasm, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
- 1
- Study location
NCT00001507: Completed Phase 1 study of Neoplasm Metastasis and Breast Neoplasm, sponsored by National Cancer Institute (NCI).
NCT00001507 is a Phase 1 study of Neoplasm Metastasis and Breast Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 107 participants, below the 413-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001507, a Phase 1 study of Neoplasm Metastasis and Breast Neoplasm, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effectiveness of combination chemotherapy with paclitaxel (Taxol) and cyclophosphamide (Cytoxan), followed by high-dose melphalan and etoposide for treating inflammatory breast cancer. Patients also receive infusions of their own previously collected progenitor cells (primitive cells that can make new cells to replace ones destroyed by chemotherapy). Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not metastasized (spread beyond the breast) may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and chest x-ray. They have computed tomography (CT) of the head, chest, abdomen and pelvis as well as a bone scan to determine the extent of disease, and a nuclear medicine scan called MUGA to examine the heart's pumping ability. They may receive a rehabilitation medicine evaluation. Participants undergo the following tests and procedures: * Central venous line placement: Patients have a central venous line (plastic tube) placed into a major vein in the chest before beginning treatment. The line remains in the body throughout treatment and is used to give chemotherapy and other medications and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. * Chemotherapy: Patients receive two or more cycles of paclitaxel and cyclophosphamide. Paclitaxel is given intravenously (I.V., through a vein) for 72 hours using a portable pump. Cyclophosphamide is given daily for 3 days I.V. over 1 hour. The cycles may be 28 days apart. A drug called Mesna is given with this treatment to protect the bladder from irritation from cyclophosphamide. Patients who have not previously been treated with doxorubicin (Adriamycin) may receive a maximum of four cycles of doxorubicin and cyclophosphamide by vein on a single day during each cycle, with cycles 21 days apart. When all the paclitaxel
Conditions Studied
Interventions
- DRUG Monoclonal Antibody 3A1
- DRUG Monoclonal Antibody 95-5-49
- DRUG Monoclonal Antibody 95-6-22
- DEVICE Baxter Isolex 3001 Stem Cell Selection System
- DEVICE Ceprate SC
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 1996-07-12 |
| Est. Completion | 2014-06-20 |
| Phase | Phase 1 |
What the finished NCT00001507 record still lists
NCT00001507 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 413-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 5 interventions - of which Monoclonal Antibody 3A1 is the first listed.
NCT00001507 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001507 about?
NCT00001507 is a clinical study titled "Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer". This study will evaluate the effectiveness of combination chemotherapy with paclitaxel (Taxol) and cyclophosphamide (Cytoxan), followed by high-dose melphalan and etoposide for treating inflammatory breast cancer. Patients also receive infusions of their own previously collected progenitor cells (pr...
What is the current status of trial NCT00001507?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 1996-07-12. Estimated completion is 2014-06-20.
What conditions does trial NCT00001507 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Breast Neoplasm.
What interventions are being tested in trial NCT00001507?
The interventions under investigation include: Monoclonal Antibody 3A1 (DRUG), Monoclonal Antibody 95-5-49 (DRUG), Monoclonal Antibody 95-6-22 (DRUG), Baxter Isolex 3001 Stem Cell Selection System (DEVICE), Ceprate SC (DEVICE).
Who is sponsoring clinical trial NCT00001507?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001507 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001507's enrollment target sits among peer trials
107 25th of 41 higher than 17 of 41 other Neoplasm Metastasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasm Metastasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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