MDACC Study Summary 2006-0803 (Archived)

Study Summary
No. 2006-0803:.......Lymphoma; Myeloma......Yago Nieto......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2006-0803

Study Title:	Gemcitabine combined with busulfan and melphalan, with hematopoietic cell transplantation, for patients with poor-prognosis advanced lymphoid malignancies

Physician

New Patient Referral



Name:	Yago Nieto	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:	Lymphoma Myeloma	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Study will terminate on transplant day +100. Patients will subsequently monitored at the discretion of their physicians.

Treatment Agents:	Busulfan Gemcitabine Melphalan	Home Care:	IV fluids, etc. as determined by patient's clinical status.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	30 days post transplant, and will include inpatient and out patient care during this time period.


Description/ Intervention:	The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.

Study Objectives / Outcomes

1. Determine the maximum tolerated dose (MTD) of Gemcitabine when administered with Busulfan and Melphalan in a previously tested regimen.
2. Describe the toxicities produced by the new three-drug regimen.
3. Derive preliminary estimates of the disease-free survival produced by this regimen.

Study Status Information



Study Activation / Registration Date:	12/08/2006

IRB Review and Approval Date:	11/01/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

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) Age 18 - <70 years.

2) Patients with lymphoid malignancies who do not qualify for treatment protocols of higher priority: 2.1) Primary refractory/recurrent Hodgkin's disease 2.2) Primary refractory/recurrent non-Hodgkin's lymphoma 2.3) Multiple myeloma beyond first remission or unresponsive to therapy, who do not qualify for higher priority melphalan-based protocols.

3) Adequate renal function, as defined by estimated serum creatinine clearance >/= 50 ml/min and/or serum creatinine </= 1.8 mg/dL.

4) Adequate hepatic function, as defined by SGOT and/or SGPT </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.

5) Adequate pulmonary function with FEV1, FVC and DLCO >/= 50% of expected corrected for hemoglobin or volume.

6) Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

7) Zubrod performance status <2.

8) Patient should be willing to participate in the study by providing written consent.

9) Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria:

1) Patients with grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to grade 1.

2) Patients with prior whole brain irradiation

3) Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >=10,000 copies/mL, or >= 2,000 IU/mL).

4) Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.

5) Active infection requiring parenteral antibiotics.

6) HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts

7) Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.

Links

Registration Number: NCT00410982
Study Information on Clinical Trials Registry (clinicaltrials.gov)