CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
filgrastim +5 morebiological
Likely dose
Doxorubicin 150 mg/m² IV continuous infusion 96 hours (Course 1); Melphalan 75 mg/m² IV (Course 2); Cisplatin 100 mg/m² IV (Course 2); Ifosfamide 14 g/m² IV continuous infusion 96 hours (Course 1); followed by peripheral blood stem cell transplantation and filgrastim 5 mcg/kg dailyAI-extracted
Key inclusion· 11
  • ✓Histologically confirmed soft tissue sarcoma (STS): high-grade extremity STS ≥10 cm or multifocal, or truncal/head-neck STS ≥10 cm or any size without surgical margin options; primary site controlled by surgery/radiotherapy
  • ✓Osteosarcoma: extremity OS post-neoadjuvant chemotherapy/surgery with <50% necrosis AND elevated LDH/alkaline phosphatase (>2× normal at presentation); or axial/metastatic OS in CR/PR after chemotherapy/surgery
  • ✓Ewing's sarcoma or PNET: primary site in CR/PR after prior therapy, OR rib/pelvic/axial primary ≥10 cm, OR metastatic disease in CR/PR
  • ✓Rhabdomyosarcoma: gross residual disease after primary treatment, OR primary group IV/recurrent metastatic disease in CR/PR
Key exclusion· 13
  • ✕Brain metastases
  • ✕Histologically confirmed bone marrow metastases (prior metastases allowed if bone marrow clear at entry)
  • ✕Contraindication to stem cell collection or autologous bone marrow harvest
  • ✕Hearing loss >40 decibels

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

Search/NCT00002601
NCT00002601Phase 2Completed
CompareCT.gov

High-Dose Doxorubicin and Ifosfamide Followed by Melphalan and Cisplatin for Patients With High-Risk and Recurrent Sarcoma

City of Hope Medical Center·interventional·Posted Mar 11, 2004·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating filgrastim, cisplatin, and 4 other interventions for Sarcoma. Completed, enrolled 13 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or recurrent sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 11, 2004
Enrollment StartSep 1, 1994
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 20 yearsPosted 22.3 years ago

Interventions

filgrastimbiological

5 ug/kg daily following stem cell reinfusion

cisplatindrug

Course 2 - 100 mg/m2 at an infusion rate of 25 mg/hr

doxorubicin hydrochloridedrug

Course 1 - 150 mg/m2 by continuous intravenous infusion for 96 hours.

ifosfamidedrug

Course 1 - 14 gm/M2 by continuous intravenous infusion for 96 hours.

melphalandrug

Course 2 - 75 mg/m2 infused at a rate of 5 mg/minute

peripheral blood stem cell transplantationprocedure

Administered on Day 0 following high-dose chemotherapy in both courses 1 and 2