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

Sponsors and Collaborators:	Duke University Pfizer
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00737113

Purpose

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

Condition	Intervention	Phase
Unrelated Umbilical Cord Blood Transplantation	Drug: Genotropin (Recombinant Human Growth Hormone)	Phase I

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title:	A Phase I Trial To Determine the Safety of Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Unrelated Cord Blood Transplantation

Further study details as provided by Duke University:

Primary Outcome Measures:

To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing unrelated cord blood transplantation [ Time Frame: After 6, 12, 18 patients have enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the incidence of mortality due to opportunistic infections in the first 6 months. [ Time Frame: After 6, 12, and 18 patients have enrolled ] [ Designated as safety issue: No ]
To evaluate the incidence and severity of infectious complications. [ Time Frame: After 6, 12, and 18 patients have enrolled ] [ Designated as safety issue: No ]
To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll. ] [ Designated as safety issue: No ]
To determine the probability and time of neutrophil and platelet recovery on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

The primary objective of this study is to define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing unrelated cord blood transplantation. The secondary objectives of this study are: to evaluate the incidence of mortality due to opportunistic infections in the first 6 months, to evaluate the incidence and severity of infectious complications, to assess laboratory parameters of post-transplant immune recovery in patients on GH therapy and to determine the probability and time of neutrophil and platelet recovery on GH therapy.

Eligibility

Ages Eligible for Study:	12 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥12 and ≤ 50 years.
<90 days following Unrelated Cord Blood 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

Exclusion Criteria:

Patients with malignancies who are not in remission at the time of transplant
Patients with malignancies that have progressed after transplant
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 concurrently involved in any clinical trial that affects GVHD.
Patients with severe veno-occlusive disease as determined by standard criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737113

Contacts

Contact: Mitchell Horwitz, MD	919-668-1045	mitchell.horwitz@duke.edu
Contact: Paul Szabolcs, MD	919-668-1100	paul.szabolcs@duke.edu

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

Pfizer

Investigators

Principal Investigator:	Paul Szabolcs, MD	Duke University
Principal Investigator:	Mitchell Horwitz, MD	Duke University

More Information

Responsible Party:	Duke University Medical Center ( Dr. Paul Szabolcs and Dr. Mitchell Horwitz )
Study ID Numbers:	Pro00001910
Study First Received:	August 15, 2008
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00737113
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

Unrelated umbilical cord blood transplant
Engrafted
subjects

ClinicalTrials.gov processed this record on January 14, 2009