MDACC Study Summary 2005-0844 (Archived)

Study Summary
No. 2005-0844:.......Hematologic Disorder; Leukemia; Lymphoma; Myeloma......Roy B. Jones......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2005-0844

Study Title:	Dose Escalation Trial of VNP 40101M and Hematopoietic Cell Transplantation for Patients with Selected, Poor-Prognosis Hematologic Malignancies

Physician

New Patient Referral



Name:	Roy B. Jones	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:	713-745-2161 Contact us about clinical trials

General Information



Disease Group:	Hematologic Disorder Leukemia Lymphoma Myeloma	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	auto tx: approx. 5 visits from day 20-30 post HCT. One visit at 3 mo. after HCT. allo tx: approx. 30-40 visits between day 25 and day 100 post HCT. These schedules are standard HCT practice, and no visits for study purposes alone are required.

Treatment Agents:	VNP4010M	Home Care:	none

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	20-30 days. This length of stay is compatible with standard HCT practice, and no additional days of hospitalization are required for unique study purposes.

Description/
Intervention:

The goal of this clinical research study is to find the highest tolerable dose
of VNP40101M in combination with fludarabine that can be given to patients with
a form of leukemia, MDS, lymphoma, or myeloma, in preparation for an allogeneic
stem cell transplant. The safety and effectiveness of this treatment
combination will also be studied.

Researchers also want to study the pharmacokinetics (PKs) of this treatment. PK
testing is the study of how drugs act in the body over time, including how they
are absorbed into the body, how they move throughout the body, and how the body
gets rid of them.

Study Objectives / Outcomes

Primary

Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT)

Secondary

Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug.
Describe and estimate the frequency of > Grade 3 non-hematologic/non-infectious toxicities at the MTD.
Report the efficacy of the regimen.
Evaluate the rate of engraftment for the regimen.

Study Status Information



Study Activation / Registration Date:	08/20/2007

IRB Review and Approval Date:	08/16/2006

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 to 65 years for autotransplant patients and age 18 to 60 years for allotransplant patients.

2) Patients with acute leukemia/MDS or lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or refractory relapse), or multiple myeloma (beyond first remission or unresponsive to therapy), not qualifying for treatment protocols of higher priority.

3) Adequate renal function, as defined by serum creatinine <1.5 mg/dL.

4) Adequate hepatic function, as defined by SGPT <3 X upper limit of normal; serum bilirubin and alkaline phosphatase <2 X upper limit of normal, or considered not attributable to liver disease in the case of alkaline phosphatase.

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

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

7) Zubrod performance status <2

8) Patients receiving an allogeneic transplant must have a related or unrelated donor which meets departmental standards for donor selection.

Exclusion Criteria:

1) Uncontrolled life-threatening infections

2) HIV positive

3) A positive Beta HCG in a woman with child bearing potential as defined as not being post-menopausal for 12 or more months or no previous surgical sterilization procedures.

4) Any CNS involvement which has not been controlled for at least 4 weeks

5) Patients must be at least 21 days from prior systemic therapy for their malignancy, or have improvement of all reversible toxicities to </= grade 2, whichever occurs first.

6) Any patient receiving Antabuse

7) Patients should be off metronidazole (Flagyl) for at least 24 hours prior to starting VNP40401M

Links

Registration Number: NCT00521859
Study Information on Clinical Trials Registry (clinicaltrials.gov)