Clinical trial NCT00299780: Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Official title: Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Multiple Myeloma
Acute Myelogenous Leukemia
Keywords: Mobilization
Stem Cell
Parathyroid Hormone
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Beth Israel Deaconess Medical Center
First posted: 2006-03-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
Secondary outcomes:
measure: To evaluate the peripheral blood CD34+ count after second mobilization.
measure: To evaluate CD34+ cells/kg from apheresis after second mobilization.
measure: To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained.
measure: To evaluate transfusion support.
measure: To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant.
measure: To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Massachusetts General Hospital, Harvard University
name: Karen Ballen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: