Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information

Alternate Title

Intrathecal Diaziquone in Treating Children With Cancer That Has Spread to the Meninges

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed over 3 NCI NCI-83-C-0039D NCI-W83-0836, W83-0836

Objectives

I.  Describe the qualitative and quantitative toxicity of 
aziridinylbenzoquinone (AZQ) administered intrathecally on a twice-weekly 
dosage schedule.

II.  Evaluate the therapeutic efficacy of intrathecal AZQ against meningeal 
spread of pediatric acute lymphoblastic leukemia, lymphoma, or solid tumors 
(including brain tumors) refractory to conventional therapy.

Entry Criteria

Disease Characteristics:

Meningeal spread of leukemia, lymphoma, or solid tumors
(including brain tumors) refractory to conventional therapy and
confirmed as follows:
  CSF cell count of at least 5/cumm and evidence of blast cells
  on cytospin preparation in patients with leukemia/lymphoma

  Tumor cells on cytospin preparation or cytology or measurable
  meningeal disease on MRI in patients with solid tumors

  No brain tumors with bulky parenchymal lesions

Prior/Concurrent Therapy:

No concurrent other intrathecal or systemic therapy designed
specifically for CNS disease

Biologic therapy:
  Recovery from toxicity of prior immunotherapy required

Chemotherapy:
  No prior aziridinylbenzoquinone
  Recovery from toxicity of prior chemotherapy required
  Concurrent systemic chemotherapy for non-CNS disease allowed

Endocrine therapy:
  Not specified

Radiotherapy:
  Recovery from toxicity of prior radiotherapy required

Surgery:
  Not specified

Patient Characteristics:

Age:
  Over 3

Performance status:
  Not specified

Life expectancy:
  At least 8 weeks

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin less than 2.0 mg/dl
  SGPT less than 3 x normal

Renal:
  Creatinine less than 1.5 mg/dl OR
  Creatinine clearance greater than 60 ml/min/1.73 sqm

Expected Enrollment

14 patients will be entered in each disease category.  If there are no 
responses in the first 14 patients entered in a disease stratum, the study 
will be closed for that stratum; if one or more responses are seen in the 
first 14 patients in a disease stratum, up to 30 patients will be entered in 
that stratum.

Outline

Single-Agent Intrathecal Chemotherapy.  Diaziquone, Aziridinylbenzoquinone, 
AZQ, NSC-182986.

Zimm S, Collins JM, Curt GA, et al.: Cerebrospinal fluid pharmacokinetics of intraventricular and intravenous aziridinylbenzoquinone. Cancer Res 44 (4): 1698-701, 1984.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Frank Balis, MD, Protocol chair		Ph: 301-496-0085 Email: balisf@nih.gov