Cancer Help Guide

Adrenocortical carcinoma · ISRCTN20220821

RADS2: Rescue of ADdiSon’s disease 2

Combined immunotherapy and trophic adrenocortical stimulation in new onset autoimmune Addison’s disease

Status
recruitment ended 2016-10-31 (ISRCTN)
Phase
Not Applicable
Sponsor
Not stated
Registry records
ISRCTN ISRCTN20220821 (recruitment ended 2016-10-31)
Registry last updated 2021-01-05

Eligibility, line by line

Not yet checkedThe eligibility text has not been analysed yet, so there is no grade. Read the criteria on the registry.
Inclusion criteria:
Part A:
1. Clear evidence of adrenocortical failure with subnormal cortisol response to 250 µg IV synacthen (peak cortisol <300nmol/l) plus either clinical or biochemical evidence to confirm elevated ACTH, or evidence of mineralcorticoid insufficiency
2. Basal or ACTH stimulated serum cortisol >50nmol/l
3. Patients are less than 4 weeks from first diagnosis of AAD
4. Positive serum 21-hydroxylase autoantibodies (>1.0 IU/l on RSR assay)
5. Normal or atrophic adrenal glands on CT scan
6. Willingness to travel to the Wilson Horne Immunotherapy Centre, Newcastle for study
7. Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration
8. Willingness to use secure contraception during and for 12 months post-treatment with rituximab ((women of childbearing potential)

For Part B, only the first 4 criteria are relevant

Exclusion criteria:
1. Active viral illness, including HIV, Hepatitis B or C, shingles/Zoster
2. Recent or partially treated TB or unexplained radiographic abnormality on chest X-ray
3 .Previous use of immunosuppressive or cytotoxic drugs (excluding glucocorticoid)
4. Significant cardio-respiratory (inc. asthma), chronic renal or non-autoimmune liver disease
5. Pregnant or breastfeeding and with plan for pregnancy/ breastfeeding within 24 months
6. Known allergy or contraindication to synacthen, synacthen depot, rituximab or methylprednisolone
Full eligibility text as the registry publishes it
Inclusion criteria:
Part A:
1. Clear evidence of adrenocortical failure with subnormal cortisol response to 250 µg IV synacthen (peak cortisol <300nmol/l) plus either clinical or biochemical evidence to confirm elevated ACTH, or evidence of mineralcorticoid insufficiency
2. Basal or ACTH stimulated serum cortisol >50nmol/l
3. Patients are less than 4 weeks from first diagnosis of AAD
4. Positive serum 21-hydroxylase autoantibodies (>1.0 IU/l on RSR assay)
5. Normal or atrophic adrenal glands on CT scan
6. Willingness to travel to the Wilson Horne Immunotherapy Centre, Newcastle for study
7. Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration
8. Willingness to use secure contraception during and for 12 months post-treatment with rituximab ((women of childbearing potential)

For Part B, only the first 4 criteria are relevant

Exclusion criteria:
1. Active viral illness, including HIV, Hepatitis B or C, shingles/Zoster
2. Recent or partially treated TB or unexplained radiographic abnormality on chest X-ray
3 .Previous use of immunosuppressive or cytotoxic drugs (excluding glucocorticoid)
4. Significant cardio-respiratory (inc. asthma), chronic renal or non-autoimmune liver disease
5. Pregnant or breastfeeding and with plan for pregnancy/ breastfeeding within 24 months
6. Known allergy or contraindication to synacthen, synacthen depot, rituximab or methylprednisolone

Routes in: how this trial is reached and paid for

  • UK access: residence, not citizenship

    Being a British citizen does not by itself entitle you to free NHS treatment; entitlement runs on being ordinarily resident in the UK.

    The UK and EU agreed to continue a planned-treatment scheme equivalent to S2 from 1 January 2021, so an S2 issued by an EU insurer is the thing to ask about for a UK trial. Put the question to both your insurer and the trial coordinator, since sponsors sometimes cover trial-related care regardless.

    Verify with: NHS: planned treatment abroad and the S2 route

    Ask both; not free by citizenship

  • Free patient navigation

    myTomorrows (Amsterdam) provides medically trained, multilingual patient navigators who search ClinicalTrials.gov, EU CTIS and ISRCTN and can support a doctor through an expanded-access application. Free to patients and families.

    A navigator keeps searching after any single page stops being current. Use it alongside this site, not instead of your oncologist.

    Verify with: myTomorrows for patients

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Sites (1)

United Kingdom

  • Institute of Genetic Medicine, Newcastle upon Tyne