CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
filgrastim +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00423852
NCT00423852Phase 2Completed

Phase I/II Trial of Sequential Paclitaxel/Ifosfamide Followed by Dose-Escalated, Dose-Intensive Carboplatin, Paclitaxel and Ifosfamide With Stem Cell Support in Cisplatin-Resistant Germ Cell Tumor Patients

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 18, 2007·Updated May 18, 2016

In Brief

A Phase 2 clinical trial evaluating filgrastim, carboplatin, and 4 other interventions for Brain and Central Nervous System Tumors and 4 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2007
Enrollment StartAug 1, 2006
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 19.5 years ago

Interventions

filgrastimbiological

carboplatindrug

ifosfamidedrug

paclitaxeldrug

autologous hematopoietic stem cell transplantationprocedure

peripheral blood stem cell transplantationprocedure