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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute
• Treatments: Hormones

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