Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant

NCT00737113 | Terminated Phase 1

• 1 other identifier: Pro00001910
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a patients undergoing allogeneic transplantation.

Conditions

Allogeneic Stem Cell Transplantation

Keywords

allogeneic stem cell transplantation; Engrafted; subjects

Outcome Measures

Primary Outcomes (1)

• To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation

  After 6, 12, 18 patients have enrolled

Secondary Outcomes (4)

• To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.

  After 6, 12, and 18 patients have enrolled

• To evaluate the incidence and severity of infectious complications.

  After 6, 12, and 18 patients have enrolled

• To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.

  After 6, 12, and 18 patients enroll.

• To determine the probability and time of neutrophil and platelet recovery on GH therapy.

  After 6, 12, and 18 patients enroll

Interventions

Genotropin (Recombinant Human Growth Hormone) DRUG

Patients will begin daily subcutaneous (SC) therapy at a starting dose of \~0.02mg/kg body weight. The study drug will continue for 90 days post enrollment.

Also known as: rh-GH, Genotropin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥12
• \<90 days following Allogeneic Transplantation.
• ANC\>500/ul for 3 consecutive days.
• ≥50% donor cells in all cellular fractions tested.
• No active grade II or higher acute graft versus host disease
• Receiving ≤ 1 mg/kg/day Methylprednisolone or equivalent
• Documentation of morphologic or radiographic remission within 45 days of protocol enrollment

You may not qualify if:

• Patients with acute organ dysfunction requiring monitoring in the Intensive Care unit or receiving invasive interventions that may include, Hemodialysis ,CVVHD, or any form of mechanical ventilation including CPAP/BiPap at the time of starting therapy.
• Pregnant or lactating patients and those without a negative pregnancy test.
• Patients must have a life expectancy of at least 3 months.
• Patients must be HIV negative.
• Patients must not be receiving investigational agents for treatment of GVHD.
• Patients with severe veno-occlusive disease as determined by standard criteria.
• Patients with Type 1 Diabetes at the time of initiation of stem cell transplantation.

Sponsors & Collaborators

• Mitchell Horwitz, MD: lead
• Pfizer: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Human Growth Hormone; Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mitchell Horwitz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

US (1)