Abscopal Effect for Metastatic Small Cell Lung Cancer

Status Withdrawn

Clinical Trial Summary

Patients with small cell lung cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.

1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung cancer patients.

2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung cancer patients;

3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.

This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic small cell lung cancer.

Clinical Trial Description

1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung cancer patients.

2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung cancer patients;

3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.

Eligible are patients with metastatic small cell lung cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least three separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 35Gy in 10 fractions over a two week interval, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with thymalfasin. Abscopal response is evaluated by assessing clinical and PET/CT response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02542137
Study type	Interventional
Source	Zhejiang Provincial People’s Hospital
Contact
Status	Withdrawn
Phase	Phase 2
Start date	September 2015
Completion date	December 2019

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03651219` - Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer	Phase 3
Active, not recruiting	`NCT03958045` - Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma	Phase 2
Completed	`NCT04381910` - Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer	Phase 2
Active, not recruiting	`NCT04885998` - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)	Phase 1
Active, not recruiting	`NCT03703297` - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy	Phase 3
Recruiting	`NCT05903092` - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer	Phase 2
Completed	`NCT03652077` - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies	Phase 1
Terminated	`NCT04422210` - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC).	Phase 1
Not yet recruiting	`NCT02875457` - Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin	Phase 3
Recruiting	`NCT02577627` - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC	N/A
Recruiting	`NCT02605811` - Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer	Phase 2
Completed	`NCT02551432` - Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer	Phase 2
Recruiting	`NCT02262897` - The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer	Phase 2
Terminated	`NCT00969306` - Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients	Phase 1
Completed	`NCT01831089` - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors	Phase 1
Completed	`NCT01943578` - Value of Physical Capacity Tests in Lung Cancer	N/A
Completed	`NCT01497873` - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer	Phase 2
Completed	`NCT00930891` - Bevacizumab in Extensive Small Cell Lung Cancer	Phase 2/Phase 3
Terminated	`NCT00958022` - Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer	Phase 1
Terminated	`NCT00702962` - Carboplatin and Etoposide in Combination With Vorinostat for Patients With Extensive Stage Small Cell Lung Cancer	Phase 1/Phase 2