Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
1 other identifier
interventional
12
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lymphoma
Started Jul 2004
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 3, 2006
CompletedFirst Posted
Study publicly available on registry
March 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedApril 24, 2007
April 1, 2007
March 3, 2006
April 23, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
Secondary Outcomes (6)
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.
- +1 more secondary outcomes
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Dana-Farber Cancer Institutecollaborator
- Beth Israel Deaconess Medical Centercollaborator
Study Sites (3)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02116, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Ballen, M.D.
Massachusetts General Hospital, Harvard University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2006
First Posted
March 7, 2006
Study Start
July 1, 2004
Study Completion
April 1, 2007
Last Updated
April 24, 2007
Record last verified: 2007-04