NCT00003545

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

Official Title:

A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL)

Summary

Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)
* Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and CD8
* Leukemia cells should be negative for myeloperoxidase or Sudan Black B If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid markers CD33 and/or CD13
* Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission
* No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy

PATIENT CHARACTERISTICS:

* Age: 16 and over
* Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
* Creatinine clearance at least 50 mL/min (unless due to leukemia)
* No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL
* No preexisting neuropathy of grade 2 or greater regardless of causality
* No history of seizure disorder
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* No concurrent erythropoietin
* No other concurrent chemotherapy
* No concurrent dexamethasone or other steroidal antiemetics
* No concurrent hormone therapy, except for non-disease-related conditions

Disease(s) and\or Condition(s)

Leukemia

Lymphoma

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: nelarabine
    • Description:
    • Arm Group Labels: Arm I
Sponsor
  • National Cancer Institute (NCI)