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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

NCT00002931 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-02-23

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.

Conditions

Interventions

BIOLOGICAL

filgrastim

5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.

DRUG

carboplatin

AUC=7, daily X 3

DRUG

etoposide

20 mg/kg by 2 hours infusion daily X 3

DRUG

ifosfamide

3 gm/m2 IV over 30 minutes X 3 days

DRUG

paclitaxel

425 mg/m2 as 24 hour continuous infusion

PROCEDURE

autologous bone marrow transplantation

Given in two divided infusions on day -2 and day 0

PROCEDURE

bone marrow ablation with stem cell support

Two cycles of high dose chemotherapy followed by stem cell reinfusion

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Sumanta Pal, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00002931 on ClinicalTrials.gov