Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization

Conditions
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Lymphoma, Multiple Myeloma, Acute Myelogenous Leukemia

Intervention / Treatment
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* Drug: Stem cell mobilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Stem cell mobilization|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the peripheral blood CD34+ count after second mobilization. |  |  | 
| To evaluate CD34+ cells/kg from apheresis after second mobilization. |  |  | 
| To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained. |  |  | 
| To evaluate transfusion support. |  |  | 
| To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant. |  |  | 
| To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobilization, Stem Cell, Parathyroid Hormone