Clinical trial NCT00003837: 506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Official title: Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Lymphoma
Keywords: recurrent adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
recurrent adult lymphoblastic lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
Secondary outcomes:
measure: Toxicity
measure: Antitumor efficacy as defined by the rate of complete hematologic responses
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
state: Florida
city: Bethesda
country: United States
facility: NCI - Pharmaceutical Management Branch
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: NCI - Investigational Drug Branch
name: Anthony J. Murgo, MD
role: STUDY_CHAIR
References: