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Completed

NCT Number: NCT00299780

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

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.

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Key information

Conditions

Lymphoma Acute Myelogenous Leukemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stem cell mobilization

Drug

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

  1. To evaluate the peripheral blood CD34+ count after second mobilization.

  2. To evaluate CD34+ cells/kg from apheresis after second mobilization.

  3. To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained.

  4. To evaluate transfusion support.

  5. To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant.

  6. To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Registry information

Official study title

Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization

Important dates

Study start
2004
Study completion
2007
First posted
Mar 7, 2006
Registry last updated
Apr 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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