MDACC Study Summary 2007-0299 (Archived)

Study Summary
No. 2007-0299:.......Blood And Marrow Transplantation......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2007-0299

Study Title:	Protocol#: SCSSc-01-01 A Randomized, Open-Label, Phase II/III Multi-Center Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis. Mechanistic Study: Pharmacokinetics of 4-hydroxycyclophosphamide in patients receiving cyclophosphamide for the SCOT trial

Physician

New Patient Referral



Name:	Chitra M. Hosing	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation	Supported By:	NIH, NIAID

Phase of Study:	N/A	Return Visit:	NA

Treatment Agents:	Antithymocyte Globulin Cyclophosphamide Radiation	Home Care:	NA

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this clinical research study is to find out the level of 4-OH-CP that is needed in your blood, and for how long that level is needed, for it to be most effective against scleroderma, while causing the least side effects. Researchers will also learn whether the first dose and second dose of the study drug have the same effect on the blood.

Study Objectives / Outcomes

This is a follow up study to protocol 2004-0721 titled: A Randomized, Open-Label, Phase II/III Multi-Center Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis. All patients enrolled on this protocol will also be registered on 2004-0721. No additional patients will be enrolled.

Primary objective:
To determine the plasma concentration and exposure time required for cyclosphosphamide to produce optimal immunosuppressive activity with minimal toxicity in subjects with severe systemic sclerosis.
Secondary objectives:
1. To determine whether the initial cyclophosphamide exposure affects the pharmacokinetics of a second dose in the cyclophosphamide arm.
2. To evaluate the effect of this high dose cyclophosphamide regimen on myelosuppression as assessed by total white cell count and that of polymorphic mononuclear cells at 24 and 48h post-dose in the transplant arm.

Study Status Information



Study Activation / Registration Date:	03/13/2009

IRB Review and Approval Date:	09/28/2007

Study Type:	Laboratory

Recruitment Status:	Terminated

Projected Accrual:	50

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) All participants included in this mechanistic study must meet the inclusion criteria for the SCOT study. No additional inclusion criteria have been established.

Exclusion Criteria:

N/A

Links

Registration Number: NCT00848614
Study Information on Clinical Trials Registry (clinicaltrials.gov)