Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.
Full description
Patients will start treatment within 21 days of the determination of inadequate mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg. PTH will be given on day 1 and continue until stem cell collections are complete or a maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off study criteria and not continue with PTH/G-CSF.
Sex
Ages
Volunteers
Inclusion criteria
- Disease status: NHL or HD refractory to chemotherapy, relapsed, o high risk first remission; multiple myeloma; AML in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder.
- Failed one or two mobilization attempts.
- ECOG performance status of 0, 1, or 2.
Exclusion criteria
- Cardiac disease: symptomatic congestive heart failure, angina pectoris or uncontrolled hypertension
- Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease.
- Renal disease: serum creatinine > 2 mg/dl
- Hepatic disease: SGOT or SGPT > 3x normal; serum bilirubin > 2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis
- Calcium > 10.5
- Phosphate < 1.6
- Uncontrolled infection
- Pregnancy or breast feeding mother
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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