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

This study has been completed.
Sponsor:
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
  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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

ClinicalTrials.gov processed this record on October 21, 2014