Status:
COMPLETED
Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Lymphoma
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 progeni...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00299780
Start Date
July 1 2004
End Date
April 1 2007
Last Update
April 24 2007
Active Locations (3)
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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