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

Primary Purpose

Lymphoma, Multiple Myeloma, Acute Myelogenous Leukemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stem cell mobilization

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Mobilization, Stem Cell, Parathyroid Hormone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Dana Farber Cancer Institute
Massachusetts General Hospital
MD Anderson Cancer Center

Outcomes

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).

Full Information

NCT ID

NCT00299780

First Posted

March 3, 2006

Last Updated

April 23, 2007

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00299780

Brief Title

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

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Multiple Myeloma, Acute Myelogenous Leukemia

Keywords

Mobilization, Stem Cell, Parathyroid Hormone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Stem cell mobilization

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To evaluate the peripheral blood CD34+ count after second mobilization.

Title

To evaluate CD34+ cells/kg from apheresis after second mobilization.

Title

To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained.

Title

To evaluate transfusion support.

Title

To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant.

Title

To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Ballen, M.D.

Organizational Affiliation

Massachusetts General Hospital, Harvard University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02116

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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