NCT00002558

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 1994

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

May 23, 2016

Completed
Last Updated

May 23, 2016

Status Verified

April 1, 2016

Enrollment Period

15.3 years

First QC Date

November 1, 1999

Results QC Date

December 21, 2015

Last Update Submit

April 11, 2016

Conditions

Extragonadal Germ Cell TumorOvarian CancerTesticular Germ Cell Tumor

Keywords

recurrent malignant testicular germ cell tumorrecurrent ovarian germ cell tumorextragonadal germ cell tumor

Outcome Measures

Primary Outcomes (1)

  • Overall Objective Response

    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 demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}

    2 years

Study Arms (1)

chemotherapy administered with G-CSF and PBSC support

EXPERIMENTAL

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.

Biological: filgrastimDrug: carboplatinDrug: etoposideDrug: ifosfamideDrug: paclitaxelProcedure: peripheral blood stem cell transplantation

Interventions

filgrastimBIOLOGICAL
chemotherapy administered with G-CSF and PBSC support
carboplatinDRUG
chemotherapy administered with G-CSF and PBSC support
etoposideDRUG
chemotherapy administered with G-CSF and PBSC support
ifosfamideDRUG
chemotherapy administered with G-CSF and PBSC support
paclitaxelDRUG
chemotherapy administered with G-CSF and PBSC support
peripheral blood stem cell transplantationPROCEDURE
chemotherapy administered with G-CSF and PBSC support

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male/Female with histologically confirmed GCT with review by the Department of Pathology at this center.
  • Patients with advanced GCT, including patients with:
  • measurable or evaluable disease,
  • patients with only elevated serum tumor markers (AFP and/or HCG), or
  • patients with known residual disease after postchemotherapy surgery. Eligible patients must have established clinical resistance to cisplatin by their failure to achieve a durable CR to a cisplatin-based regimen.
  • Prior treatment limited to ≤ 6 prior cycles (≤ four cycles preferred) of cisplatin. (GROUP A)
  • Prior therapy \> 6 cycles of cisplatin. (GROUP B)
  • Therapy must have been discontinued at least 3 weeks before entry onto protocol.
  • Patients must have one or more unfavorable prognostic factors for achieving a CR to cisplatin-based salvage therapy. These are:
  • Extragonadal primary site.
  • Testis/ovarian primary site with the best response of an IR to first-line therapy, or a partial response with normal tumor markers of six months or less in duration.
  • Prior treatment with ifosfamide-containing therapy
  • General medical condition sufficient to allow for general anesthesia at the time of pheresis catheter placement.
  • Patients must have negative serology for Human Immunodeficiency Virus.
  • Laboratory criteria for protocol entry:
  • +4 more criteria

You may not qualify if:

  • Presence of active infection
  • Concurrent treatment with chemotherapy or
  • Inability to comply with the treatment protocol or to undergo the specified follow-up tests for safety or effectiveness.
  • Prior high-dose therapy with AuBMT.
  • Patients must have recovered from recent surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (2)

  • Feldman DR, Sheinfeld J, Bajorin DF, Fischer P, Turkula S, Ishill N, Patil S, Bains M, Reich LM, Bosl GJ, Motzer RJ. TI-CE high-dose chemotherapy for patients with previously treated germ cell tumors: results and prognostic factor analysis. J Clin Oncol. 2010 Apr 1;28(10):1706-13. doi: 10.1200/JCO.2009.25.1561. Epub 2010 Mar 1.

    PMID: 20194867RESULT

  • Kondagunta GV, Bacik J, Sheinfeld J, Bajorin D, Bains M, Reich L, Deluca J, Budnick A, Ishill N, Mazumdar M, Bosl GJ, Motzer RJ. Paclitaxel plus Ifosfamide followed by high-dose carboplatin plus etoposide in previously treated germ cell tumors. J Clin Oncol. 2007 Jan 1;25(1):85-90. doi: 10.1200/JCO.2006.06.9401.

    PMID: 17194908RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsTesticular Germ Cell TumorTesticular Neoplasms

Interventions

FilgrastimCarboplatinEtoposideIfosfamidePaclitaxelPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Robert Motzer
Organization
Memorial Sloan Kettering Cancer Center
motzerr@mskcc.org
646-422-4312

Study Officials

  • Gnanamba V. Kondagunta, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1994

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 23, 2016

Results First Posted

May 23, 2016

Record last verified: 2016-04

Locations

US(1)