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JOURNAL ONKOLOGIE – STUDIE

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Rekrutierend

NCT-Nummer:
NCT02375204

Studienbeginn:
März 2015

Letztes Update:
08.03.2021

Wirkstoff:
ifosfamide, pegylated G-CSF, etoposide phosphate, Paclitaxel, Cisplatin, G-CSF, Carboplatin

Indikation (Clinical Trials):
Neoplasms, Neoplasms, Germ Cell and Embryonal, Teratoma, Endodermal Sinus Tumor, Seminoma, Choriocarcinoma, Germinoma

Geschlecht:
Männer

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Alliance for Clinical Trials in Oncology

Collaborator:
National Cancer Institute (NCI), European Organisation for Research and Treatment of Cancer - EORTC, Movember Foundation, Institute of Cancer Research (ICR), United Kingdom, Cancer Research UK, UNICANCER, Irish Group CTI,

Studienleiter

Darren Feldman, MD
Study Chair
Memorial Sloan Kettering Cancer Center

Kontakt

Studienlocations
(3 von 116)

University of Berlin Charite Campus Benjamin Franklin
12203 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 888-823-5923
E-Mail: ctsucontact@westat.com
» Ansprechpartner anzeigen
University of Dusseldorf
40225 Dusseldorf
(Nordrhein-Westfalen)
GermanySchwebend» Google-Maps
University Hospital Ulm
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 49 731 500-56022
E-Mail: studienzentrum.cccu@uniklinik-ulm.de
» Ansprechpartner anzeigen
UC San Diego Moores Cancer Center
92093 La Jolla
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Florida Health Science Center - Gainesville
32610 Gainesville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 352-273-8010
E-Mail: cancer-center@ufl.edu
» Ansprechpartner anzeigen
Johns Hopkins All Children's Hospital
33701 Saint Petersburg
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Joseph's Hospital/Children's Hospital-Tampa
33607 Tampa
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 813-357-0849
E-Mail: jennifer.manns@baycare.org
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Northwestern University
60611 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
Rush University Medical Center
60612 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Illinois
60612 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Chicago Comprehensive Cancer Center
60637 Chicago
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 773-702-8222
E-Mail: cancerclinicaltrials@bsd.uchicago.edu
» Ansprechpartner anzeigen
University of Michigan Comprehensive Cancer Center
48109 Ann Arbor
United StatesAktiv, nicht rekrutierend» Google-Maps
Memorial Sloan Kettering Monmouth
07748 Middletown
United StatesSchwebend» Google-Maps
UNC Lineberger Comprehensive Cancer Center
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 877-668-0683
E-Mail: cancerclinicaltrials@med.unc.edu
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University of Oklahoma Health Sciences Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 405-271-8777
E-Mail: ou-clinical-trials@ouhsc.edu
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Prisma Health Cancer Institute - Spartanburg
29316 Boiling Springs
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 864-522-2066
E-Mail: kim.williams3@prismahealth.org
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Prisma Health Cancer Institute - Butternut
29605 Greenville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 864-522-2066
E-Mail: kim.williams3@prismahealth.org
» Ansprechpartner anzeigen
Prisma Health Greenville Memorial Hospital
29605 Greenville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 864-522-2066
E-Mail: kim.williams3@prismahealth.org
» Ansprechpartner anzeigen
Prisma Health Cancer Institute - Eastside
29615 Greenville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 864-522-2066
E-Mail: kim.williams3@prismahealth.org
» Ansprechpartner anzeigen
El Paso Children's Hospital
79905 El Paso
United StatesSchwebend» Google-Maps
M D Anderson Cancer Center
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Marshfield Medical Center-EC Cancer Center
54701 Eau Claire
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org
» Ansprechpartner anzeigen
Marshfield Medical Center-Marshfield
54449 Marshfield
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org
» Ansprechpartner anzeigen
Marshfield Clinic-Minocqua Center
54548 Minocqua
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org
» Ansprechpartner anzeigen
Marshfield Medical Center-Rice Lake
54868 Rice Lake
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org
» Ansprechpartner anzeigen
Marshfield Clinic Stevens Point Center
54482 Stevens Point
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org
» Ansprechpartner anzeigen
Marshfield Medical Center - Weston
54476 Weston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-782-8581
E-Mail: oncology.clinical.trials@marshfieldresearch.org
» Ansprechpartner anzeigen
Centre Alexis Vautrin
54511 Vandoeuvre-les-Nancy
FranceSchwebend» Google-Maps
Ospedale di Circolo di Busto Arsizio
21052 Busto Arsizio
ItalySchwebend» Google-Maps
Hospital De La Santa Creu I Sant Pau
08025 Barcelona
SpainSchwebend» Google-Maps
Duran i Reynals Hospital-Catalan Institute of Oncology
08908 Barcelona
SpainSchwebend» Google-Maps
Hospital General Universitario Morales Meseguer
30008 Murcia
SpainSchwebend» Google-Maps
Hopitaux Universitaires de Geneve
1211 Geneva
SwitzerlandSchwebend» Google-Maps
Weston Park Hospital
S10 2SJ Sheffield
United KingdomSchwebend» Google-Maps
Saint James's University Hospital
LS9 7TF West Yorkshire
United KingdomSchwebend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The study is an international collaboration with European sites. Collaborators on the study

include the National Cancer Institute, the European Organization for Research and Treatment

of Cancer and the Movember Foundation. Randomization will be stratified by region (North

America and Europe) and by modified IPFSG (International Prognostic Factor Study Group) risk

classification (low, intermediate and high). The primary and secondary objectives are

described below.

Primary Objective:

1. To compare the overall survival in patients treated with conventional-dose chemotherapy

using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant

(ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or

refractory germ cell tumors (GCT)

Secondary Objectives:

1. To compare the progression-free survival (PFS) of patients treated with initial salvage

HDCT with TI-CE versus initial salvage CDCT with TIP

2. To compare the favorable response rate (FRR) of patients treated with initial salvage

HDCT with TI-CE versus initial salvage CDCT with TIP

3. To compare the toxicity, including treatment-related mortality, associated with

high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy

using TIP as initial salvage treatment for patients with relapsed or refractory GCT

4. To prospectively evaluate the IPFSG scoring system as a predictor of outcome to initial

salvage therapy in patients with relapsed or refractory GCT. In this trial,

randomization will be stratified by a modification of their IPFSG category and we will

prospectively evaluate whether or not actual outcomes vary by risk group in the

appropriate manner (low risk patients have higher OS than high-risk group).

5. To evaluate the association between tumor marker decline rates of Alpha-Fetoprotein

(AFP) and Human Chorionic Gonadotropin (HCG) with OS and PFS.

Treatment is to continue until disease progression, unacceptable toxicity or completion of

all protocol treatment.

Ein-/Ausschlusskriterien

1. Documentation of Disease

- Histologic Documentation: Confirmation of GCT histology (both seminoma and

nonseminoma) on pathologic review at the center of enrollment.

- Tumor may have originated in any primary site. NOTE: In rare circumstances,

patients will be allowed to enroll even if a pathologic diagnosis may not have

been established.

- This would require a clinical situation consistent with the diagnosis of GCT

(testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor

marker levels {HCG ≥ 500; AFP ≥ 500} and typical pattern of metastases)

2. Evidence of Disease

- Must have evidence of progressive or recurrent GCT (measurable or non-measurable)

following one line of cisplatin-based chemotherapy, defined as meeting at least

one of the following criteria:

- Tumor biopsy of new or growing or unresectable lesions demonstrating viable

non-teratomatous GCT (enrollment on this study for adjuvant treatment after

macroscopically complete resection of viable GCT is not allowed). In the

event of an incomplete gross resection where viable GCT is found, patients

will be considered eligible for the study.

- Consecutive elevated serum tumor markers (HCG or AFP) that are increasing.

Increase of an elevated LDH alone does not constitute progressive disease.

- Development of new or enlarging lesions in the setting of persistently

elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.

3. Prior Treatment

- Must have received 3-6 cycles of cisplatin-based chemotherapy as part of

first-line (initial) chemotherapy.

- Prior POMBACE, CBOP-BEP, or GAMEC are allowed.

- Note: For patients requiring immediate treatment, 1 cycle of

conventional-dose salvage chemotherapy is allowed. Therefore, these patients

may have received 7 prior cycles of chemotherapy. 6 cycles as part of

first-line chemotherapy and 1 cycle of salvage conventional chemotherapy.

- No more than one prior line of chemotherapy for GCT (other than the 1 cycle of

salvage chemotherapy as defined in the protocol)

- Definition of one line of chemotherapy: One line of therapy can in some

cases consist of 2 different cisplatin-based treatment combinations,

provided there is no disease progression between these two regimens.

- Prior treatment with carboplatin as adjuvant therapy is allowed, provided

patients meet other eligibility criteria (e.g., the patient has also

received 3-4 cycles of cisplatin-based chemotherapy).

- Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for

early stage GCT is allowed, provided the patient also received 3-4 cycles of

BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at

relapse following 1-2 cycles of BEP/EP are not eligible as this would be

considered more than 1 line of prior therapy.

- No prior treatment with high-dose chemotherapy (defined as treatment utilizing

stem cell rescue)

- No prior treatment with TIP with the exception when given as a bridge to

treatment on protocol for patients with rapidly progressive disease who cannot

wait to complete the eligibility screening process. Only one cycle is allowed.

- No concurrent treatment with other cytotoxic drugs or targeted therapies.

- No radiation therapy (other than to the brain) within 14 days of day 1 of

protocol chemotherapy except radiation to brain metastases, which must be

completed 7 days prior to start of chemotherapy.

- No previous chemotherapy within 17 days prior to enrollment. A minimum of three

weeks after the last day of the start of the previous chemotherapy regimen before

the first day of chemotherapy on study protocol.

- Must have adequate recovery from prior surgery (eg, healed scar, resumption of

diet)

4. Age ≥ 14 years (≥ 18 years in Germany)

5. ECOG Performance Status 0 to 2

6. Male gender

7. Required Initial Laboratory Values:

- Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3

- Platelet Count ≥ 100,000/mm^3

- Calculated creatinine clearance ≥ 50 mL/min

- Bilirubin ≤ 2.0 x upper limits of normal (ULN)

- AST/ALT ≤ 2.5 x upper limits of normal (ULN)

8. No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive

(pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell

neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence

of disease are allowed.

9. Negative Serology (antibody test) for the following infectious diseases:

- Human Immunodeficiency Virus (HIV) type 1 and 2

- Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in

Canada and Europe)

- Hepatitis B surface antigen

- Hepatitis C antibody

10. No late relapse with completely surgically resectable disease. Patients with late

relapses (defined as relapse ≥ 2 years from the date of completion of the last

chemotherapy regimen) whose disease is completely surgically resectable are not

eligible. Patients with late relapses who have unresectable disease are eligible.

11. No large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment

has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days

after completion of local treatment. Patients with small (< 2 cm) and asymptomatic

brain metastases are allowed and may be treated with radiation therapy and/or surgery

concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated.

Radiation therapy should not be given concurrently with high-dose carboplatin or

etoposide.

12. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant

transformation) when it is actively part of the disease recurrence or progression.

Studien-Rationale

Primary outcome:

1. overall survival (Time Frame - Up to 36 months post-treatment)



Secondary outcome:

1. progression free survival (Time Frame - Up to 36 months post-treatment)

2. proportion of patients achieving either a complete response (CR) or partial response (Time Frame - Up to 3 months post-registration)

3. treatment related mortality (Time Frame - Up to 30 days post-treatment)

4. number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Time Frame - Up to 3 months post-registration)

5. Validation of International Prognostic Factor Study Group stratification system (eg, primary site, prior response, progression free interval) (Time Frame - Up to 3 years post-registration)

Studien-Arme

  • Other: Arm A: TIP
    Patients will receive treatment for 4 cycles administered every 21 days. Cycles 1-4 (1 cycle = 21 days) paclitaxel 250 mg/m^2 IV over 24 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) ifosfamide 1500 mg/m^2 IV daily on Days 2-5 with mesna protection as defined in the protocol cisplatin 25 mg/m^2 IV daily on Days 2-5 pegylated G-CSF 6 mg subcutaneous on Day 6 or 7 or G-CSF as defined in the protocol on Days 6-18 Patients may commence with each Arm A cycle provided they meet the criteria as defined in the protocol.
  • Other: Arm B: TI-CE
    Patients will receive treatment for a total of 5 cycles. Cycles 1-2 (1 cycle = 14 days) paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) ifosfamide 2000 mg/m^2 IV daily on Days 1-3 with mesna protection as defined in the protocol G-CSF 10 µg/kg subcutaneously on Days 3-15 (cycle 1) and Days 3-14 (cycle 2) or pegylated G-CSF 6 mg subcutaneous on Day 4 or 6 (cycle 1) and Day 4 or 5 (cycle 2) leukapheresis every 14 days, if there is an inadequate number of CD34+ cells/kg collected in cycle 1 Cycles 3-5 (1 cycle = 21 days) carboplatin daily on Days 1-3 etoposide 400 mg/m^2 daily on Days 1-3 stem cell reinfusion on day 5 pegylated G-CSF 6 mg subcutaneously or G-CSF at approximately 5 µg/kg daily on Days 5-15 Patients may commence with each Arm B cycle provided they meet the criteria as defined in the protocol.

Geprüfte Regime

  • paclitaxel (Taxol):
    IV
  • ifosfamide (Ifex®, IFOS):
    IV
  • cisplatin (CDDP):
    IV
  • pegylated G-CSF:
    IV
  • G-CSF:
    IV
  • carboplatin (Paraplatin®, CBDCA):
    IV
  • etoposide phosphate (VePesid®, Toposar®, VP16):
    IV
  • stem cell reinfusion:
    surgical procedure

Quelle: ClinicalTrials.gov


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