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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00299780

Collaborator

Dana-Farber Cancer Institute (Other), Beth Israel Deaconess Medical Center (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Multiple Myeloma Acute Myelogenous Leukemia	Drug: Stem cell mobilization	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2004

Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

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

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02116
3	MD Anderson Cancer Center	Houston	Texas	United States	77030