A study of GCS-100 in combination with chemo-immunotherapy in patients with diffuse large B-cell lymphoma which have relapsed or are refractory to treatment
| ISRCTN | ISRCTN66315383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66315383 |
| Secondary identifying numbers | PR-CS011 |
- Submission date
- 15/10/2008
- Registration date
- 30/10/2008
- Last edited
- 16/10/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rebecca Auer
Scientific
Scientific
St Barts and the London NHS Trust
Dept Medical Oncology
St Barts Hospital
45 Little Britain
West Smithfield
London
EC1A 7BE
United Kingdom
Study information
| Study design | Interventional, single-arm, single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A phase II study of GCS-100 in combination with chemo-immunotherapy in relapsed or refractory diffuse large B-cell lymphoma |
| Study objectives | The primary objective of this study is to assess the efficacy of GCS-100 with rituximab, ifosfomide, mesna, carboplatin and etoposide (R-ICE) chemotherapy in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The secondary objective is to determine the safety of GCS-100 in conjunction with cytotoxic chemotherapy. |
| Ethics approval(s) | The study was approved by the London Research Ethics Committee (REC) of Northwick Park Hospital on the 6th October 2008 (ref: 08/H0718/57) |
| Health condition(s) or problem(s) studied | Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) |
| Intervention | This is a single-arm trial of GCS-100 with R-ICE chemotherapy administered in 21-day cycles (a maximum of four chemotherapy cycles per participant). Each 21-day treatment cycle consists of the following: Days 1 - 5: GCS-100 160 mg/m^2/day intravenously (IV) over 1 hour. Dosing with GCS-100 will be followed at least 1 hour later by: Day 1: rituximab 375 mg/m^2 IV Days 2: carboplatin dose area under the curve (AUC) = 5 mg/mL x min (maximum 800 mg) IV Days 2 - 4: ifosfamide 1667 mg/m^2 IV Days 2 - 4: mesna 1667 mg/m^2 IV or oral Days 2 - 4: etoposide 100 mg/m^2 IV |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | GCS-100, rituximab, ifosfomide, mesna, carboplatin, etoposide |
| Primary outcome measure | 1. Response: overall response rate, defined as the sum of the number of CR rate and PR rate. CR and PR will be defined according to the International Harmonisation Project for Lymphoma criteria. 2. Imaging: CT scans will be obtained at baseline and every two cycles to assess for response. They will be evaluated according to the International Harmonisation Project for Lymphoma. Total duration of follow-up for the primary and secondary outcome measures: 16 weeks. |
| Secondary outcome measures | To determine the safety of GCS-100 in conjunction with cytotoxic chemotherapy by collecting adverse event data and monitoring blood parameters, etc. Total duration of follow-up for the primary and secondary outcome measures: 16 weeks. |
| Overall study start date | 01/12/2008 |
| Completion date | 01/12/2009 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 14 - 28 |
| Key inclusion criteria | 1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent 2. Subject is male or female, aged at least 18 years 3. Subject has histologically confirmed DLBCL, bidimensionally measurable by computerised tomography (CT) scan, with at least one lesion greater than or equal to 1.5 cm in the greatest diameter. CT scan results must be available prior to dosing to establish eligibility. 4. Subject has relapsed or relapsed/refractory disease following at least two cycles of R-ICE chemotherapy as salvage chemotherapy, without partial response (PR) or complete response (CR) 5. Subject has greater than or equal to 4 weeks elapsed between last chemotherapy or immunotherapy exposure 6. Subject has Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1 |
| Key exclusion criteria | 1. Subject has received high-dose chemotherapy with haematopoietic stem cell support or allogeneic stem cell transplantation (SCT) 3. Subject has rapidly progressive lymphoma or lymphoma threatening organ function 4. Subjects with primary or secondary central nervous system lymphoma 5. Subjects who have had treatment with an experimental (unlicensed) drug within 3 weeks prior to treatment with GCS-100 6. Subject has not recovered from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy 7. Subject has a known history of human immunodeficiency virus-related lymphoma, active hepatitis C, active hepatitis B, or prior history of infection with hepatitis B (HBcAb positive) 8. Subject has a clinically relevant active infection and/or a serious co-morbid medical condition such as recent myocardial infarction (within the last 6 months and no electrocardiographic evidence of acute ischaemia or new conduction system abnormalities), unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis. 9. Subject had major surgery within 4 weeks prior to study day 1 |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Barts and the London NHS Trust
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Prospect Therapeutics, Inc. (USA)
Industry
Industry
12 Gill Street
Suite 4700
Woburn
MA 01801
United States of America
| Website | http://www.prospectthera.com |
|---|
Funders
Funder type
Industry
Prospect Therapeutics, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
