A Phase I study of 4-(N-(S-penicillaminylacetyl)amino) phenylarsonous acid (PENAO) given as a continuous intravenous infusion, to patients with advanced solid tumours
University of NSW
35 participants
Jul 17, 2012
Interventional
Conditions
Summary
The main aim of the study is to work out the safest dose of PENAO to give to patients. PENAO is an organoarsenic which means it is related to arsenic. There are other drugs in this class which are used to treat different forms of cancer. In this research study patients will be given a new drug, PENAO, for the first time. This drug has been previously safely tested in animals but has not been tested before in humans. Because of this, it is unknown what the most effective and safe dosage level should be. Secondly, the study aims to monitor patients to collect more information about how the drug is broken down by the body and do scans to observe whether the drug has an effect on tumours. To date, this drug has been shown to slow or stop the growth of many different types of tumours when grown in mice. PENAO is an experimental drug. This means that it is not an approved treatment for cancer in Australia or other parts of the world. This study drug was developed by a group of researchers at the University of NSW as an anti-cancer agent. This research and the clinical study are funded by the Cancer Institute of NSW.
Eligibility
Inclusion Criteria9
- Histologically or cytologically confirmed advanced solid tumour refractory to standard treatment or for which no standard treatment exists.
- Patients with primary CNS malignancy must be seizure free for at least 28 days and on stable (i.e. not increasing) doses of anticonvulsants and corticosteroids in that time frame, and be on a maximum corticosteroid dose of 2 mg/day dexamethasone (or bioequivalent dose of other agent) at study enrolment.
- Aged greater than or equal to 18 years.
- ECOG performance status of 0 to 1.
- Life expectancy of greater than 3 months.
- GFR greater than equal to 65 mL/min
- Normal cardiac function, parameters are defined.
- Minimum intervals since most recent systemic and local therapies are defined.
- Threshold haematological and biochemical parameters are defined.
Exclusion Criteria10
- Currently receiving therapeutic anticoagulant therapy.
- Known HIV infection or active HBV infection.
- Receiving medications associated with prolongation of Q-Tc interval.
- Pre-existing > Grade I Peripheral Neuropathy.
- Known brain metastases
- Baseline proteinuria (by dipstick) or history of glomerular renal disease.
- Body Mass Index >30.
- History of allergic reactions to arsenic compound(s).
- Uncontrolled intercurrent illness or psycho-social dysfunction.
- Patients who are pregnant or breast feeding.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
4-(N-(S-penicillaminylacetyl)amino) phenylarsonous acid (PENAO) PENAO will be administered as a continuous intravenous infusion, using a centrally placed infusion line and a portable pump. Patients will be enrolled and assessed in groups of 3 patients per cohort. If no defined severe toxicity is observed, then 3 new patients will be treated at the next higher dose level. If some defined severe toxicity is observed, the cohort may be expanded to 6 patients or recognised as the Maximum Active Drug Level. The starting dose of PENAO will be 2.0 mg/m2/day over 4 days (96 hours) in every 21 day cycle. Subsequent cohorts/groups of patients will receive the same daily dose over periods of 7 days, 14 days and 21 days. Once the feasibility of a 21 day infusion is determined, this schedule will be maintained and the daily dose will then be increased between cohorts. Subsequently daily dose increases are predefined in the protocol, and range between 30-40% of the previous safe dose.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000908831