MDACC Study Summary 2004-0639 (Archived)

Study Summary
No. 2004-0639:.......Leukemia......Susan O'Brien......Leukemia

Study Summary Title



Study Summary Number:	2004-0639

Study Title:	A Phase III Randomized study of CLORETAZINE® (VNP40101M) and Cytosine Arabinoside (AraC) in Patients with Acute Myeloid Leukemia in First Relapse

Physician

New Patient Referral



Name:	Susan O'Brien	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7543 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	2 to 3 times weekly

Treatment Agents:	Cytarabine VNP4010M	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	4 days


Description/ Intervention:	The goal of this clinical research study is to learn if treatment with CLORETAZINEā (VNP40101M) plus cytarabine is more effective compared to cytarabine plus placebo in patients with AML who have had their first relapse of disease. The safety and effectiveness of these drugs will also be studied.

Study Objectives / Outcomes

Primary-
To determine if the regimen of CLORETAZINE^ā (VNP40101M) and cytarabine (ara-C) increases the rate of CR/CRp compared to placebo and cytarabine in AML patients in first relapse.
Secondary
To compare CLORETAZINE^ā (VNP40101M)/araC versus placebo/araC with regard to the following:
-Time-to-progression or death from any cause
- Duration of response
- Survival
- Toxicity

Study Status Information



Study Activation / Registration Date:	02/28/2005

IRB Review and Approval Date:	10/20/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	420

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) Patients must have AML (any WHO classification excluding acute promyelocytic leukemia) in first relapse after a first CR or CRp determined by bone marrow aspirates and/or biopsies that contain >/= 10% blasts. The duration of first CR or CRp must have been at least 3 months but less than 24 months, calculated from the day CR or CRp was documented following the initial induction regimen to the day leukemia relapse was confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology and/or histological proven CNS or extramedullary disease.

2) There is no restriction on number of regimens or type of treatment required to induce first CR (or CRp) or number of regimens or type of treatment administered for consolidation in first CR (or CRp).

3) Patients cannot have received any treatment other than hydroxyurea in first relapse. Hydroxyurea should be discontinued at least 12 hours prior to initiation of protocol treatment.

4) Age >/= 18

5) ECOG performance status of 0-2.

6) Women of child-bearing potential (i.e., women who are premenopausal or not surgiaclly sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods. Pregnant and nursing patients are excluded because the effects of Cloretazine® (VNP40101M) on a fetus or nursing child are unknown.

7) Must be able and willing to give written informed consent and comply with requirements of the protocol.

8) Patients must have the following clinical laboratory values: (1) Serum creatinine less than or equal to 2.0 mg/dl; (2) Total bilirubin </= 1.5 x the upper limit of normal; (3) Aspartate aminotransferase (AST, SGOT) </= 3 x the upper limit of normal.

Exclusion Criteria:

1) Uncontrolled active infection of any kind. Patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered to the study. Patients with chronic hepatitis are eligible.

2) Uncontrolled invasive fungal infection (positive blood cultures or tissues cultures).

3) Myocardial infarction within previous 3 months, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.

4) Patients receiving any other standard or investigational treatment for their leukemia.

5) Clinical evidence by tumor marker, pathology, or radiologic studies of an active second malignancy.

6) Presence of any other severe medical condition that may compromise the safety of treatment, for example, severe chronic obstructive pulmonary disease, or requirement for supplemental oxygen at rest.

7) Because the Cloretazine® (VNP40101M) formulation contains 30% ethanol, concurrent use of disulfiram (Antabuse) or Flagyl is prohibited. Patients willing to discontinue Antabuse and/or Flagyl use at least 24 hours prior to study entry may be enrolled. Antabuse and/or Flagyl should not be restarted until 24 hours after the last dose of any protocol cycle.

Links

Registration Number: NCT00112554
Study Information on Clinical Trials Registry (clinicaltrials.gov)