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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299780
First Posted: March 7, 2006
Last Update Posted: April 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Information provided by:
Massachusetts General Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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
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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299780


Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116
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

ClinicalTrials.gov Identifier: NCT00299780     History of Changes
Other Study ID Numbers: 04-109
First Submitted: March 3, 2006
First Posted: March 7, 2006
Last Update Posted: April 24, 2007
Last Verified: April 2007

Keywords provided by Massachusetts General Hospital:
Mobilization
Stem Cell
Parathyroid Hormone

Additional relevant MeSH terms:
Multiple Myeloma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs