None listed
Conditions
Brief summary
This study aims to evaluate the safety, tolerability and preliminary efficacy of 3 different doses of a cancer vaccine, manufactured from a patient's own tumour. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have banked a tumour sample in the Regeneus Tumour Bank (ACTRN12615000476538) and your tumour is inoperable and non-treatable or current treatment is refractory. Study details All patients enrolled in this safety and tolerability study will have their banked tumour samples used to develop a tumour specific vaccine. In brief, the vaccine is manufactured from the tumour, which is homogenised, processed and combined with streptavidin, an immunostimulant. Tumour cells are burst open during this process so that only the tumour proteins remain, i.e. no viable tumour cells remain in the vaccine. At the bedside, the vaccine is mixed with Freund’s Incomplete Adjuvant (FIA), which assists in immune recognition. Patients are given a single, small volume vaccine into the skin on Weeks 1, 4, and 7. Three different dose levels of streptavidin will be assessed (100, 250 or 500 ug) to identify the dose that is biologically active. Safety and tolerability will be assessed over a 24 week period by recording adverse event information, vital signs, physical examinations and various laboratory assessments. CT or MRI scans and blood samples will also be taken over this period for determination of your response to the vaccine. It is hoped that this study will aid in the treatment of solid tumours by harnessing a patient's own immune system to target and destroy cancer proteins.
Interventions
RGSH4K is a vaccine formulated from a patient's own tumour material. Briefly, the tumour cells are lysed or burst to release the proteins and tumour associated antigens. The proteins are further processed in a proprietary procedure and combined with streptavidin, a novel immunostimulant. No live, viable cells remain in the vaccine. Vaccines are prepared on study entry, are stored frozen, and provided individually for injection at Weeks 1, 4 and 7.
Three (3) doses of streptavidin are being asse
RGSH4K is a vaccine formulated from a patient's own tumour material. Briefly, the tumour cells are lysed or burst to release the proteins and tumour associated antigens. The proteins are further processed in a proprietary procedure and combined with streptavidin, a novel immunostimulant. No live, viable cells remain in the vaccine. Vaccines are prepared on study entry, are stored frozen, and provided individually for injection at Weeks 1, 4 and 7. Three (3) doses of streptavidin are being assessed in this study: 100 ug, 250 ug, and 500 ug. Each set of vaccines manufactured is unique to each patient and will therefore be a unique batch. The vaccine is admixed with 200 uL of Freund's Incomplete Adjuvant immediately before administration. Three (3) vaccines in total are administered: Week 1, Week 4, and Week 7. Each vaccine is given as a single, small volume injection intradermally.
Sponsors
Regeneus Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Summary: - aged 18 years or over - has banked approximately 1 gram of fresh frozen tumour in the Regeneus tumour bank - have advanced solid tumours which are inoperable or refractory to treatment, or chemoradiotherapy is contraindicated, or where standard treatments have failed or do not exist, or in a palliative setting where the patient has refused chemotherapy or it is contraindicated.
Exclusion criteria
- Rapidly progressing malignancy - History of organ transplant and/or current immunosuppressive therapy, current systemic corticosteroids - concurrent anticancer therapy, or within 4 weeks of vaccine - Autoimmune disease - known positive HIV or tests positive to HIV
Outcome results
None listed