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


N/A
16 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Anthony J. Murgo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Investigational Drug Branch

Authority:

United States: Federal Government

Study ID:

CDR0000066994

NCT ID:

NCT00003837

Start Date:

September 1999

Completion Date:

November 2007

Related Keywords:

  • Leukemia
  • Lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • T-cell adult acute lymphoblastic leukemia
  • recurrent adult lymphoblastic lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
City of Hope Comprehensive Cancer CenterDuarte, California  91010
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
NCI - Pharmaceutical Management BranchBethesda, Maryland  20892