Ongoing Clinical Trials

 

ITMIG CLINICAL TRIALS LIST (Last updated April 26,2017)

 

   Locally Advanced (Includes both Perioperative and Definitive)

Trial Name

Phase

Inclusion

Primary Outcome

Status

Group/Trial Number

PI/Contact

Concurrent chemoradiotherapy followed by surgical resection for stage III thymic tumors.

2

Stage III thymic tumors (thymoma/thymic carcinoma)

Rate of complete resection

Active, not recruiting

(Accrual finished. Under follow-up)

China (Shanghai)

ChART

ChiCTR-TNC-10001204

Changlu Wang

Shanghai Chest Hospital

#86-21-62821990  luise2w@msn.com

Sequential chemoradiotherapy followed by surgical resection for locally advanced thymic tumors

2

Locally invasive, include stage IV

ORR

Recruiting

 

China (Shanghai)

ChART

ChiCTR-OIC-16009130

Fang Wentao 

# +86 18017321389

vwtfang@hotmail.com    

 

Wang Changlu

Shanghai Chest Hospital

#86 18017321628

luise2w@msn.com 

A Phase II Trial of Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma

2

-Newly diagnosed or recurrent thymoma or thymic carcinoma

-No prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic biopsy) for thymoma

-Clinical Masaoka Stage II (>5cm), III, or IVA

Complete pathologic response

Active, not recruiting

US:

Memorial Sloan Kettering Cancer Center (NY and NJ)

City of Hope (CA)

MD Anderson (Texas)

NCT01025089

James Huang, MD

Memorial Sloan Kettering Cancer Center

#646-888-3055

A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)

2

- Thymic carcinoma unresectable locally advanced

-ECOG PS 0-1

ORR

Recruiting

(open public recruiting)

Japan (Nagasaki)

-Clinical Research Support Center Kyushu

-Lung Oncology Group in Kyushu (LOGIK)

-JART

UMIN000024643

Minoru Fukuda

Nagasaki University Hospital

mifukuda258@nifty.com

 

(1)Minoru Fukuda

(2) Takuya Yamazaki

#095-819-7779

mifukuda258@nifty.com

Phase II Study of Concurrent Chemoradiotherapy for Inoperable Locally Advanced (Stage III/IVA) Thymoma or Thymic Carcinoma

2

-Masaoka stage III or IVa thymoma or thymic carcinoma

-ECOG PS 0-2

PFS

Recruiting

 

China (Shanghai)

NCT02636556

Kailiang Wu, M.D.,Ph.D

Fudan University

# 86 64175590 ext 86722

wukailiang@aliyun.com

 

Yu Yang

#86 15055127520 842093447@qq.com

 

 

   Surgery

Trial Name

Phase

Inclusion

Primary Outcome

Status

Group/Trial Number

PI/Contact

A multicenter prospective observational study to evaluate the role of lymph node metastasis and lymphadenenctomy in the surgical management of thymic tumors.

Other/

retrospective

- Thymic malignancies, treatment naïve, underwent surgical resection with curative intent

Incidence of lymph nodal involvement

Active, not recruiting

(Accrual finished. Abstract accepted for presentation at AATS 2017)

China (Shanghai)

Many other institutions involved through ChART

ChiCTR-TNC-16009163

 

Wentao Fang

#86-18017321389

vwtfang12@shchest.org

 

Zhitao Gu 

Shanghai Chest Hospital

#86 18017321357 

guzhitao0717@hotmail.com 

Phase II Study of Thymomectomy for Thymoma Localized in the Thymus

2

-Clinically diagnosed as thymoma localized in the thymus

Local recurrence rate five and ten years after the operation

Active, not recruiting

(no longer recruiting)

Japan (Nagoya)

JART

UMIN000000614

 

Yoshitaka Fujii

Nagoya City University Graduate School of Medical Sciences

#52-853-8231

Motoki Yano

#052-853-8231 motoki@med.nagoya-cu.ac.jp

**Clinical trial on Efficacy and Safety of the Next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies with dissemination and malignant pleural effusions

2

-Multiple tumor types, could include thymic for this cohort:

Hypotonic lavage and cisplatin treatment for the other thoracic malignancies (sarcomas, metastases, thymomas, etc.)

Feasibility study

Recruiting

Japan (Miyazaki)

UMIN000015343

Takanori AYABE, University of Miyazaki

#0985-85-2291

tayabe@med.miyazaki-u.ac.jp

 

 

   Post Operative and Other Radiation

Trial Name

Phase

Inclusion

Primary Outcome

Status

Group/Trial Number

PI/Contact

A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

3

-Masaoka stage II-III WHO B type thymoma

-interval of surgery to radiotherapy < 2months

 

3 year local control rate

Recruiting

China (Beijing)

 

NCT02014805

 

 

Qinfu Feng, M.D

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

#8610-87788503

13811300221@163.com

 

Ye Zhang, M.D.

#8610-87788504

drzye1983@163.com 

 

Shuting Li, Ph.D.   

#861087788495

cancergcp@163.com   

An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

3

- Pathologically confirmed Masaoka stage II or III thymoma

- complete resection within 3 months

- ECOG PS 0-2

DFS

Recruiting

China (Shanghai)

NCT02633553

Kailiang Wu, MD.PhD.

Fudan University

# 86 64175590 ext 86722

wukailiang@aliyun.com

 

Yu Yang

niujiu99@sina.com

A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete Resection Thymoma or Thymic Carcinoma

3

- Pathologically confirmed thymic tumor

- Incomplete resection (R1 or R2)

-ECOG PS 0-2

PFS

Recruiting

China (Shanghai)

NCT02633514

 

 

Kailiang Wu, MD.PhD

Fudan University

# 86 64175590 ext 86722

wukailiang@aliyun.com

 

Yu Yang

842093447@qq.com

**OTHER RADIATION

Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers

2

-Includes thymoma

-Patients must have received prior radiation treatment to the chest at least 3 months prior to enrollment in this trial

Grade 3 or greater toxicity attributable to radiation treatment

Recruiting

US:

University of Washington

NCT02204761

Jing Zeng

#206-598-4100

jzeng13@uw.edu

 

 

Intensity modulated radiation therapy for pleural recurrence of thymoma 

1/2

-Thymoma resected or well controlled by previous treatment with pleural recurrence

Local response rate

Recruiting

China (Shanghai)

 

ChiCTR-ONC-12002095 

Changlu Wang

Shanghai Chest Hospital

#86-21-62821990

 luise2w@msn.com

 

 

   Metastic First Line Systemic Therapy

Trial Name

Phase

Inclusion

Primary Outcome

Status

Group/Trial Number

PI/Contact

Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma

2

-Invasive recurrent or metastatic thymoma

- No previous chemotherapy and immunotherapy

-ECOG PS 0-1

ORR

Active, not recruiting

(no longer recruiting)

Japan (Tokyo)

West Japan Oncology Group

UMIN000003933

Keita Kudo

Cancer Institute hospital

#03-3520-0111

 

Shinichiro Nakamura

#06-6633-7400, datacenter@wjog.jp

Phase II trial of Cisplatin and Irinotecan treatment as palliative-intended chemotherapy for previously untreated advanced thymic carcinoma

2

-Thymic carcinoma and previously untreated

-ECOG PS 0-1

ORR

Recruiting (open to public recruiting)

Japan (Tokyo)

UMIN0000

Hosomi, Yuki

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

#03-3823-2101

yhosomi@cick.jp

 

Okuma, Yusuke

#03-3823-2101l

y-okuma@cick.jp

 

 

 

 

   Metastic Second Line and Beyond Systemic Therapy

Trial Name

Phase

Inclusion

Primary Outcome

Status

Group/Trial Number

PI/Contact

A Phase II Study of MK-3475 (Pembrolizumab) in Patients With Thymic Carcinoma

2

-Histologic confirmation of thymic carcinoma

-Advanced disease not amenable to curative treatment

-At least 1 prior line of chemotherapy

- Absence of any autoimmune syndrome

-ECOG PS 0-2

ORR

Recruiting

US:

Georgetown University (D.C.)

NCT02364076

 

 

Giuseppe Giaccone, MD PhD

Georgetown University

 

Colleen McGuire, RN   

#202-687-4510   

mcguirec@georgetown.edu

 

Lisa Ley, RN   

#292-687-6653

leyl@georgetown.edu

A Phase II Study of Pembrolizumab for Patients With Thymic Epithelial Tumor Who Progressed After at Least One Previous Regimen of Cisplatin-Containing Chemotherapy

2

-Thymic epithelial tumor (TET) patients

- Inoperable or metastatic disease

- More than one previous chemotherapy including at least one platinum-based regimen

ORR

Not Yet recruiting

South Korea (Seoul)

NCT02607631

Myung-Ju Ahn

Samsung Medical Center

# 82-2-3410-3438

silkahn@skku.edu

**Phase II Study for the Evaluation of Efficacy of Pembrolizumab (MK-3475) in Patients With Rare Tumors

2

-Includes thymoma group (among other rare tumors)

-failed prior treatment within 6 months

-ECOG PS 0-1

Non-Progression Rate (NPR)

Recruiting

US:

MD Anderson (Texas)

NCT02721732

Aung Naing MD

MD Anderson

#713-563-1930

 

 

 

 

Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma; PRIMER trial

2

-Thymic carcinoma, unresectable or metastatic or recurrent

-ECOG PS 0-1

- received at least one previous platinum-based chemo (radio) therapy

ORR

Suspended*

 

Japan (Tokyo)

UMIN000022007

Hidehito Horinouchi

National Cancer Center Hospital

# 03-3542-2511

hhorinou@ncc.go.jp

 

Tamie Sukigara

#03-3542-2511

tsukigar@ncc.go.jp

 

 

A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy

2

-Unresectable thymoma or thymic carcinoma who have previously been treated with at least one platinum-containing chemotherapy regimen

-ECOG PS<1

Safety

 

ORR

Recruiting

US:



National Cancer Institute (NCI) (Maryland)

NCT03076554

Arun Rajan MD

NCI

#888-624-1937

 

Maureen F Connolly

#(301) 451-4406

connollymf@mail.nih.gov

Phase II study of WT-1 pulsed dendritic cell immunotherapy as a 2nd line treatment for patients with advanced/recurrent thymic carcinoma

2

- Advanced/recurrent thymic carcinoma who have previously been treated with at least one chemotherapy regimen

-ECOG PS 0-1

PFS

Pre-initiation

Japan (Fukushima)

UMIN000023543

Hiroyuki Suzuki, Fukushima Medical University

#024-547-1111 hiro@fmu.ac.jp

 

A Phase II Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas

2

-Histological confirmation of thymoma

-At least one prior line of platinum-based chemotherapy (unless refused or not tolerated)

 

ORR

Recruiting

US:

Indiana University

NCT02220855

Patrick Loehrer, M.D

Indiana University

#317-274-3539

ploehrer@iupui.edu

 

John Spittler, R.N.   

#317-274-0771 ajspittl@iupui.edu   

Phase II Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

2

-Invasive recurrent or metastatic thymoma or thymic carcinoma

-at least one prior platinum-containing chemotherapy regimen

DCR

Active, not recruiting

Italy (Rozzano)

NCT02049047

Armando Santoro, MD

Istituto Clinico Humanitas

-No phone # or email provided

A Phase II Study of Sunitinib in Patients With Advanced Relapsed or Refractory Thymoma or Thymic Carcinoma With at Least One Prior Line of Platinum-Based Systemic Chemotherapy

2

-Histological confirmation of thymoma (Group 1 only) or thymic carcinoma

- At least one prior line of platinum-based chemotherapy or patient must have refused cytotoxic chemotherapy

-ECOG PS< 2

ORR

Active, not recruiting

US:

National Cancer Institute

Indiana University School of Medicine

NCT01621568

Arun Rajan MD/NCI

#888-624-1937

 

Arlene Berman

#301-435-5609

arleneb@mail.nih.gov

 

A Phase II, Non-comparative, Open Label, Multi-center Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma

2

-Metastatic or recurrent thymic carcinoma

- ECOG PS 0-2

- Documented progressive disease after one or more conventional systemic chemotherapy

ORR

Active, not recruiting

South Korea (Seoul)

NCT02623127

Jong Seok Lee, MD, PhD Seoul National University Bundang Hospital

#2-31-787-1376

jslee@snubh.org   

Phase II trial of Lenvatinib in patients with metastatic or recurrent thymic carcinoma; REMORA trial

2

- Thymic carcinoma, unresectable, metastatic, or recurrent

- at least one previous platinum-based chemo (radio) therapy

-ECOG PS 0-1

ORR

Recruiting

(open to public recruiting)

Japan (Tokyo)

UMIN000026777

Noboru Yamamoto; National Cancer Center Hospital

# 03-3542-2511

nbryamam@ncc.go.jp

 

Tomomi Hata

#03-3542-2511

tomhata@ncc.go.jp

Phase II Study Of Oral PHA-848125AC (Milciclib Maleate) In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

2

- Unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease

-ECOG PS 0-1

PFS rate at 3 months

Active, not recruiting

Multi-country

 

US:

-Georgetown University Hospital

-NCI

Italy:

-Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

NCT01301391

 

 

PI :

US: Arun Rajan MD, Giuseppe Giaccone MD

Italy: Marina Garassino MD

Phase II Study Of Oral PHA-848125AC (Milciclib Maleate)  In Patients With Thymic Carcinoma Previously Treated With Chemotherapy

2

-Unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)

-ECOG PS 0-1

PFS rate at 3 months

Active, not recruiting

Multi-country

US:

-TGen Clinical Research Services at Scottsdale Healthcare (Arizona)

-NCI (Maryland)

France:

-Hopital Larrey

-Institut de cancerologie Gustave Roussy

Italy:

-Fondazione IRCCS , Istituto Nazionale dei Tumori di Milano

-Azienda Ospedaliera San Luigi Gonzaga

NCT01011439

US: Glen Weiss, MD, Arun Rajan, MD

 

France: Benjamin Besse MD, Julien Mazières, MD

 

Italy: Silvia Novello, Marina C Garassino, MD

**Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

1

-includes thymoma and thymus cancer

DLT/MTD

Recruiting

US:

University of Cincinnati (Ohio)

NCT03023319

Nagla Karim, MD

University of Cincinnati

#513-584-7698

kastla@ucmail.uc.edu

**Pilot Trial of Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies

2

- Thymic malignancies for whom surgical resection or multimodality therapy with curative intent is not feasible

Effectiveness of genetic analysis in determining targeted therapy

Recruiting

US:

National Cancer Institute (NCI)

NCT01306045

 

 

Udayan Guha, M.D.

NCI

#301-402-3524

udayan.guha@nih.gov

 

Arlene W Berman, R.N

(301) 435-5609 arleneb@mail.nih.gov

Phase II study of S-1 for relapsed or refractory thymoma or thymic carcinoma

2

- Thymoma or thymic carcinoma

- at least 1 prior chemotherapy

-ECOG PS 0-2

ORR

Recruiting

(open to public recruiting)

Japan (Sendai)

North Japan Lung Cancer Group

UMIN000008174

Akira Inoue

Tohoku University Hospital

# +22-22-717-8539

akinoue@idac.tohoku.ac.jp

 

Alt:

+81-22-717-8539

Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma

2

-Thymic carcinoma

- previous treatment (surgery, radiotherapy, or chemotherapy

-ECOG PS 0-2

ORR

Active, not recruiting

 

(no longer recruiting)

Japan (Tokyo)

 

UMIN000010736

Hosomi, Yuki

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

#03-3823-2101

yhosomi@cick.jp

 

Okuma, Yusuke

#03-3823-2101l

y-okuma@cick.jp

 

 

Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients

2

-Thymic carcinoma unresectable or recurrent

- One or more prior chemotherapy or chemoradiotherapy

-ECOG PS 0-2

 

ORR

Enrolling by invitation

Japan (Matsumoto)

 

UMIN000004230

Shintaro Kanda; Shinshu University School of Medicine

#0263-37-2631

shintarokanda@gmail.com

A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies

2

- Invasive or metastatic thymoma or thymic carcinoma

- Previous treatment with at least one prior chemotherapy regimen.

-ECOG PS 0-1

ORR

Active, not recruiting- has results

US:

 

Stanford  (CA)

 

Indiana University (IN)

 

NCT01364727

Heather Wakelee

Stanford University

 

 

**Phase I/II Evaluation of Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases

1/2

Multiple cohorts but includes measurable inoperable thymic epithelial neoplasms

- had, or refused first-line standard chemotherapy

-ECOG PS 0-2

MTD

 

ORR

Not yet recruiting

US:

 

National Cancer Institute (Maryland)

 

NCT02859415

David S Schrump, M.D.

 

Tricia Kunst, R.N

#301-451-1233

kunstt@mail.nih.gov

 

 

**Phase I Study of TRC102 in Combination With Cisplatin and Pemetrexed in Patients With Advanced Solid Tumors, With Expansion Cohort in Mesothelioma / Phase II Study of TRC102 With Pemetrexed in Patients Refractory to Pemetrexed and Cisplatin or Carboplatin

1

-ARM A dose level 4 includes thymoma patients  (histologically proven chemotherapy-naive advanced unresectable solid tumors for which pemetrexed combined with cisplatin is an indicated regimen)

Safety

Recruiting

US CTEP Study:

 

National Cancer Institute

 

Many other sites around US

 

NCT02535312

Marianna Koczywas

City of Hope Comprehensive Cancer Center LAO

#800-826-4673

becomingapatient@coh.org  

 

 

   Other (Non-Interventional)

Trial Name

Phase

Inclusion

Primary Outcome

Status

Group/Trial Number

PI/Contact

Analysis for interstitial fluid pressure of thymoma

1

-Thymoma or mediastinal tumor thought to be thymoma

To examine whether there is correlation between interstitial fluid pressure of thymoma and prognostic factor for thymoma

Active, not recruiting

 

(no longer recruiting)

Japan (Kumamoto)

 

 

UMIN000003491

 

Takeshi Mori

Kumamoto university Hospital

 

Takeshi Mori

#096-373-5533, morimori@fc.kuh.kumamoto-u.ac.jp

 

**Nationwide registry for patients with pancreatic, gastroenteral, bronchopulmonary, and thymic neuroendocrine tumors in Japan

Registry

- Any type of thymic neuroendocrine tumors

Registry

Recruiting

 

(open to public recruiting)

Japan (Osaka)

 

The Japan Neuroendocrine Tumor Society

 

UMIN000016380

Masayuki Imamura

Kansai Electric Power Hospital

#06-6458-5821

jnets-office@umin.ac.jp

 

Toshihiko Masui

#075-751-3242

jnets-office@umin.ac.jp

Study on Regulation of LncRNA to Regulatory B Cells(Bregs) Through Notch Pathway in Patients With Thymoma and Autoimmune Diseases

Observational

-Thymoma +/- AI/PN

Relationship between LncRNA and Notch2 signaling pathway

Recruiting

 

China  (Tianjin)

 

NCT02948855

Donghao Wang

Tianjin Medical University Cancer Institute and Hospital

Wanhua_wang1962@outlook.com

 

Yang Lu

#022-23340123 ext 1021

Yang_lu1299@hotmail.com

 

Yang Yang

#022-23340123 ext 1021

yyicu3021@126.com

The Role of the Thymus in Myasthenia Gravis

 

Observational

-Compelling indications for thymectomy due to thymoma (with or without myasthenia gravis)

Not specified

Active, not recruiting

 

Germany (Berlin)

 

NCT01102192

Andreas Meisel, MD

Charite University

 

**SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

Observational but could direct patients to trials

- Pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage

Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials

Recruiting

Europe (EORTC)

NCT02214134

Benjamin Besse, MD, PhD Gustave Roussy, Cancer Campus

 

Aleksandra Peric, PhD

#32-2-774-10-43

Aleksandra.peric@eortc.be

 

Eleonora De Maio, MD

Eleonora.demaio@eortc.be

 

 

French National Observatory of Patients With Thymic Epithelial Tumor

Observational

-Thymic epithelial tumor

Histologic type and stage

Recruiting

France

RYTHMIC

NCT02724696

Benjamin BESSE, Dr

Villejuif - Gustave Roussy

 

Frank Morin

contact@ifct.fr

**Integrated Cancer Repository for Cancer Research

Biospecimen banking

-includes thymus cancer

Web-based Cancer Collaborative Registry

Recruiting

US:

University of Nebraska

NCT02012699

Whitney Goldner MD

University of Nebraska

 #402-559-3579 wgoldner@unmc.edu

 

Alice Kueh MS

#402-559-8511

akueh@unmc.edu