Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00299780
First received: March 3, 2006
Last updated: April 23, 2007
Last verified: April 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Multiple Myeloma Acute Myelogenous Leukemia |
Drug: Stem cell mobilization |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
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).
| Estimated Enrollment: | 12 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | April 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299780
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02116 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Karen Ballen, M.D. | Massachusetts General Hospital, Harvard University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00299780 History of Changes |
| Other Study ID Numbers: | 04-109 |
| Study First Received: | March 3, 2006 |
| Last Updated: | April 23, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Mobilization Stem Cell Parathyroid Hormone |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013