None listed
Conditions
Interventions
An inter-patient dose escalation of oral albendazole according to the following schema:
-1. 400mg daily, day 1 - 7 every 28 days
1. 400mg twice daily, day 1 - 7 every 28 days
2. 400mg twice daily, day 1 - 14 every 28 days
3. 400mg 3 times per day, day 1 - 14 every 28 days
4. 800mg twice daily, day 1 - 14 every 28 days
5. 800mg twice daily, day 1 - 14 every 21 days
6. 1200mg morning 800mg afternoon, day 1 - 14 every 21 days
7. 1200mg twice daily, day 1 - 14 every 21 days
Dose will be increa
An inter-patient dose escalation of oral albendazole according to the following schema: -1. 400mg daily, day 1 - 7 every 28 days 1. 400mg twice daily, day 1 - 7 every 28 days 2. 400mg twice daily, day 1 - 14 every 28 days 3. 400mg 3 times per day, day 1 - 14 every 28 days 4. 800mg twice daily, day 1 - 14 every 28 days 5. 800mg twice daily, day 1 - 14 every 21 days 6. 1200mg morning 800mg afternoon, day 1 - 14 every 21 days 7. 1200mg twice daily, day 1 - 14 every 21 days Dose will be increased if no dose limiting toxicity occurs. If one occurs, the cohort will be will be expanded to 6. If it recurs the dose limiting toxicity has been identified and no further dose increase will occur.
Sponsors
St George Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically proven advanced or metastatic cancer2. Patients must have measurable (by imaging studies such as CT but not bone scan) or evaluable disease 3. Refractory to conventional treatments 4. A maximum of two previous systemic myelosuppressive chemotherapy regimens.5. Eastern Co-operative Oncology Group score (ECOG) 0-3 performance status.6. Patients with previously treated CNS (central nervous system) metastases are eligible, provided there is no clinical or radiological evidence of on-going CNS disease progression.7. Patients must have recovered from the reversible side effects of prior therapy.8. At least 3 weeks since prior chemotherapy (at least 6 weeks for agents known to be toxic to stem cells such as nitrosoureas, melphalan, or mitomycin).9. At least 2 weeks since any prior radiotherapy. No more than 25% of bone marrow may have been irradiated in the past.10. Patients of all races and ethnic backgrounds are eligible.11. Adequate Haematological function12. Absolute neutrophils > 1,500/mm3, platelets > 100,000/mm3, 13. bilirubin < 2x upper limit normal 14. Alanine amino transferase/aspartate amino transferase < 10 x upper limit of normal, 15. Calculated creatinine clearance > 60 mls/min.
Exclusion criteria
1. Patients with unresolved ongoing infection requiring treatment.2. Decompensated liver disease with non malignant ascites or coagulopathy or encephalopathy3. Severe comorbidity at the discretion of the investigators4. Pregnancy or breast feeding mothers.
Outcome results
None listed