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

Completed · Phase 1

Conditions studied: Lymphoma, Multiple Myeloma, Acute Myelogenous Leukemia

In brief

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.

Key facts

Study ID

NCT00299780

Run by

Massachusetts General Hospital

People needed

12

Starts

2004-07-01

Expected to finish

2007-04-01

Last updated by the study team

2007-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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