506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00003837

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Drug: nelarabine	N/A

Detailed Description

OBJECTIVES:

Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.

OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for one year and then every 6 months until death.

PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Primary Purpose:

Treatment

Official Title:

Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma

Study Start Date :

Sep 1, 1999

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority []

Secondary Outcome Measures

Toxicity []
Antitumor efficacy as defined by the rate of complete hematologic responses []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
Tumor cells should exhibit phenotypic characteristics of these diseases
No CNS involvement requiring intrathecal or craniospinal radiotherapy
Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority

PATIENT CHARACTERISTICS:

Age:

16 and over

Performance status:

ECOG 0-3 OR
Karnofsky 40-100%

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 2.0 mg/dL

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 50 mL/min

Other:

No neuropathy grade 2 or higher
No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
No active seizure disorder
No active infection
No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior bone marrow transplantation allowed
No concurrent allogeneic bone marrow transplantation

Chemotherapy:

At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
No prior 506U78

Endocrine therapy:

No concurrent systemic steroid therapy

Radiotherapy:

See Disease Characteristics
Prior radiotherapy allowed

Surgery:

Not specified

Other:

No other concurrent investigational therapy
No concurrent treatment for seizures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
2	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida	United States	33612
3	NCI - Pharmaceutical Management Branch	Bethesda	Maryland	United States	20892
4	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
5	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
6	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5047
7	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283