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Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

NCT00432094 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-05-17

Study results available
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Summary

RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival.

PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.

Conditions

Interventions

DRUG

carboplatin

Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes

DRUG

etoposide

600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3.

DRUG

ifosfamide

2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.

DRUG

paclitaxel

225 mg/m\^2 intravenous over 3 hours on Day -7.

DRUG

thiotepa

150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4

PROCEDURE

autologous hematopoietic stem cell transplantation

Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)

DRUG

Mesna

2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.

BIOLOGICAL

filgrastim

Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Najla El Jurdi, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-19
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432094 on ClinicalTrials.gov