This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour infusion once weekly for 8 weeks.
Patients with solid tumors who either failed to initially respond to approved chemotherapy or who have progressive solid tumor cancers following initial response to approved chemotherapy, are eligible for treatment in this phase 1b trial of ascending doses of intravenous liposomal curcumin following a four week period without previous chemotherapy.The escalating dose range of liposomal curcumin will be from 100mg/M2 to 300 mg/M2 in cohorts of three to 6 patients, and administered over eight hours by a syringe pump weekly for eight weeks. Safety and tolerability will be determined by drug related adverse symptoms(if any), hematologic and serologic signs at each clinic visit and by electronic communication between visits. Pharmacokinetic profiles following infusion of drug will be compared with any adverse changes, and any beneficial subjective or objective responses. When the maximum tolerated dose level is reached in any cohort , another three patients will be accrued at a preceding dose level to assure tolerability in subsequent phase 2 clinical trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
3 Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
Salzburg, Austria
3. Medizinische Universitatesclinik, Haematologie, Internistische Onkologie
Salzburg, Austria
Dose limiting toxicity with focus on hemolysis
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Time frame: Eight(8) weeks
Determine the maximum tolerated dose of lipocurc
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Time frame: in the cohort after eight ( 8) weeks of treatment
Maximum tolerated dose
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Time frame: eight(8) weeks
Maximum tolerated dose defined by < Grade 1 hematologic toxicity,
The MTD is reached when two or more patients (out of 6) at a dose level experience DLT.
Time frame: Outcome measured weekly x 8 weeks
Response by Recist criteria
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
Time frame: Eight(8) weeks
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Tumor response by resist criteria
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
Time frame: 8 weeks
Tumor response
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
Time frame: Eight weeks
Benefit
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of related beneficial effect associated with the treatment.
Time frame: Eight(8) weeks
Objective change in measurable tumor size by Resist criteria
Time frame: once after 8 weeky treatments