Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients (Chloroquine IV)
Chloroquine might very well be able to increase overall survival in small cell lung cancer by sensitizing cells resistant to chemotherapy and radiotherapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Chloroquine as an Anti-autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients: A Phase 1 Trial|
- To determine the toxicity of adding chloroquine in escalating doses in SCLC patients: to standard dose cisplatin-etoposide in extensive disease SCLC; to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Tumor response (according to RECIST) [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Chloroquine
Patients receive Chloroquine
Drug: Chloroquine, A-CQ 100
Tumor hypoxia is a well-known factor negatively influencing outcome in many solid tumors, including small cell lung cancer. Hypoxic cells are more radio-resistant, more chemo-resistant and more prone to develop distant metastases than normoxic cells.
One of the mechanisms responsible for survival of these therapy-resistant hypoxic cells is (macro-)autophagy: a phenomenon in which cells provide themselves with energy (ATP) by digesting their own cell-organelles. Chloroquine is a potent blocker of autophagy and has been demonstrated in a lab setting to dramatically enhance tumor response to radiotherapy, chemotherapy and even anti-hormonal therapy.
Thus, chloroquine might very well be able to increase overall survival in small cell lung cancer by sensitizing cells resistant to chemotherapy and radiotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969306
|Contact: Bart Reymen||+31 88 44 55 email@example.com|
|NKI/AvL||Not yet recruiting|
|VU Medical Center||Not yet recruiting|
|Maastricht Radiation Oncology||Recruiting|
|Contact: Bart Reymen +31 88 4455666 firstname.lastname@example.org|
|Sub-Investigator: Dirk De Ruysscher, MD, PhD|
|Maastricht University Medical Center||Not yet recruiting|
|Contact: Annemarie Dingemans, MD +31 387 65 43|
|Sub-Investigator: Annemarie Dingemans, MD|
|Principal Investigator:||Philippe Lambin, DM, PhD||Maastricht Radiation Oncology|