506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia - Tabular View

Tracking Information

First Received Date ^ICMJE

July 5, 2000

Last Updated Date

July 23, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

Official Title ^ICMJE

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-Cell Acute Lymphoblastic Leukemia (ALL)

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia.

Detailed Description

OBJECTIVES:

Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78.
Determine the frequency and severity of toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18 months.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Drug: nelarabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of acute lymphocytic leukemia (ALL)
- FAB class L1-L2
Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)
- Coexpression of myeloid antigens CD13 or CD33 allowed
Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed
- CD3 and myeloperoxidase marker negative
Meeting 1 of the following criteria for recurrent/refractory disease:
- Refractory to standard induction regimen including at least vincristine and prednisone
- Recurrence after response after prior induction therapy
- Recurrence and failure on subsequent treatment
No CNS involvement
Must be registered on SWOG-S9910 and SWOG-9007

PATIENT CHARACTERISTICS:

Age:

16 and over

Performance status:

Zubrod 0-3

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT or SGPT no greater than 3 times ULN

Renal:

Creatinine no greater than 2 times ULN

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No grade 2 or greater neuropathy
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00006020

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068032, SWOG-S0010

Study Sponsor ^ICMJE

Southwest Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Steven E. Coutre, MD

Stanford University

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP