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NCT00002558 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT00002558: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00002558 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002558, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing them or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed. The design of this trial is a phase I/II trial of sequential accelerated chemotherapy cycles with taxol/ifosfamide and carboplatin/etoposide administered with G-CSF and PBSC support. PURPOSE: The purpose of this study is to determine the effects of an intensive sequence of chemotherapy drugs in patients with metastatic germ cell cancer. All of these chemotherapy drugs are known to be active in this disease.
Primary Outcome
Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demon
Interventions
- DRUG carboplatin
- DRUG paclitaxel
- DRUG etoposide
- DRUG ifosfamide
- BIOLOGICAL filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 1994-01 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00002558 record still lists
NCT00002558 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT00002558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00002558 about?
NCT00002558 is a clinical study titled "Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors". RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing them or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy...
What is the current status of trial NCT00002558?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 1994-01. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00002558?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), etoposide (DRUG), ifosfamide (DRUG), filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00002558?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00002558's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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