ovel treatment of patients with Advanced Cancers using a combination of commonly available, low cost oral medications.

Phase 2

• Conditions: Glioblastoma,; Metastatic Melanoma; Oral cavity Squamous cell carcinoma; Head and Neck skin Squamous cell carcinoma; Cancer - Brain; Cancer - Malignant melanoma; Cancer - Other cancer types; Cancer - Head and neck

• Registration Number: ACTRN12619001078145
• Lead Sponsor: Gillies McIndoe Research Institute

Brief Summary

The key trial findings are summarised below: • The study medications are safe and well-tolerated • The trial showed an increase of 5 months in survival however this was not statistically significant because of the small number of participants

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-05
• Study Completion: 2021-10-27
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Patients with the types of cancer listed below who have exhausted conventional treatment options where further conventional treatment has a low prospect of a beneficial outcome.
They will have a Kanofsky score of at least 60 and good performance status.
Patients may be undergoing palliative care.
OCSCC-(Oral cavity squamous cell carcinoma)
HNsSCC-(Head and Neck skin squamous cell carcinoma)
GBM-(Glioblastoma)
MM-(metastatic melanoma)

Exclusion Criteria

Exclusion Criteria
(1)Cancer patients who have a life expectancy of less than 6 months and/or the state of terminal decline;
(2)Patients with a Karnovsky score <60
(3)Patients who have failed the reasonable general health assessment and deemed not to have good performance status;
(4)Patients who are not motivated including noncompliance, e.g. continue to smoke, abuse
alcohol
(5)Children less than 16 years
(6)Patients who are older than 80 years;
(7)Patients who are not competent to give consent personally
(8)Patients who are currently participating in or have received an investigational treatment within 30 days or 5 half­lives of the investigational drug, whichever is longer
(9)Presence of contraindications to any of the study treatments including asthma/CORD, drug allergies, medications that interfere with the treatment
(10)Presence of significant immune compromise including HIV infection, organ transplant patients on immunosuppression, chronic lymphocytic leukaemia
(11)Patients who are pregnant or plan to be pregnant
(12) Patients with renal impairment
(13)Presence of a terminal organ failure
(14)A second cancer that is not expected to impact on the results of the study.
(15)Diabetic patients requiring treatment except those treated with Metformin.
(16) Connective tissue disorders.
(17)Patients who are on medications that increase renin levels such as calcium channel blockers and dieuretics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified