Busulfan in Treating Children and Adolescents With Refractory CNS Cancer

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Brief Title

Busulfan in Treating Children and Adolescents With Refractory CNS Cancer

Official Title

Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis

Brief Summary

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

      PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children and
      adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this
      treatment regimen.
    

Detailed Description

      OBJECTIVES:

        -  Determine the qualitative and quantitative toxicities of intrathecally administered
           busulfan in children and adolescents with refractory CNS malignancies.

        -  Determine the maximum tolerated dose of this treatment regimen in these patients.

        -  Determine the cerebrospinal fluid and serum pharmacokinetics of this treatment regimen
           in these patients.

        -  Determine the efficacy of this treatment regimen in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive intrathecal busulfan twice a week, at least 3 days apart, for 2 weeks.
      Patients with complete or partial response or stable disease may continue therapy once a week
      for 2 weeks, once a week every other week for 2 treatments, and then once a month thereafter
      in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of busulfan until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
      experience dose limiting toxicities.

      Patients are followed every 3 months for the first year, every 6 months for 4 years, and then
      annually for 5 years.

      PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study over 18-38
      months.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Toxicities of IT administered busulfan in children and adolescents with refractory CNS malignancies


Condition

Brain and Central Nervous System Tumors

Intervention

busulfan


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

28

Start Date

November 2000


Primary Completion Date

May 2003

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed CNS malignancy, including any of the following:

               -  Primary malignant brain tumor refractory to standard therapy and metastatic to
                  the cerebrospinal fluid (CSF) or leptomeningeal subarachnoid space

               -  Recurrent or persistent leptomeningeal leukemia, lymphoma, or germ cell tumor
                  refractory to conventional therapy

                    -  In second or greater relapse

                    -  CSF white blood count greater than 5 cells/mm3 with blasts on cytospin OR

                    -  Evidence of leptomeningeal tumor by MRI

          -  No concurrent bone marrow disease

          -  No obstruction or compartmentalization of CSF flow on CSF flow study

        PATIENT CHARACTERISTICS:

        Age:

          -  3 to 21

        Performance status:

          -  Lansky 50-100% (under 10 years)

          -  Karnofsky 50-100% (10 to 21 years)

        Life expectancy:

          -  Greater than 8 weeks

        Hematopoietic:

          -  Absolute neutrophil count greater than 1,000/mm^3

          -  Platelet count greater than 75,000/mm^3

        Hepatic:

          -  Bilirubin normal for age

          -  ALT and AST less than 5 times upper limit of normal (ULN)

          -  No hepatic disease

        Renal:

          -  Creatinine no greater than 1.5 times ULN OR

          -  Glomerular filtration rate greater than 70 mL/min

          -  No renal disease

        Cardiovascular:

          -  No cardiac disease

        Pulmonary:

          -  No pulmonary disease

        Other:

          -  No uncontrolled infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

          -  At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine) and
             recovered

          -  Evidence of subsequent disease progression

          -  Concurrent systemic chemotherapy allowed for recurrent disease after first course of
             treatment except for the following:

               -  Chemotherapy targeted at leptomeningeal disease

               -  Other phase I agent

               -  Any agent that significantly penetrates the CSF (e.g., high dose methotrexate
                  greater than 1 g/m2, thiotepa, high dose cytarabine, fluorouracil, IV
                  mercaptopurine, nitrosoureas, or topotecan)

               -  Any agent that causes serious unpredictable CNS side effects

        Endocrine therapy:

          -  Prior dexamethasone allowed with decreasing or stable dose at least one week before
             study

          -  Concurrent dexamethasone or prednisone with chemotherapy regimen allowed

        Radiotherapy:

          -  At least 1 week since prior focal irradiation to the brain or spine

          -  At least 8 weeks since prior craniospinal irradiation

          -  No concurrent cranial or craniospinal irradiation

        Surgery:

          -  Not specified

        Other:

          -  No other concurrent intrathecal or systemic therapy for leptomeningeal disease
      

Gender

All

Ages

3 Years - 21 Years

Accepts Healthy Volunteers

No

Contacts

Sri Gururangan, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00006246

Organization ID

CDR0000068178

Secondary IDs

PBTC-004


Study Sponsor

Pediatric Brain Tumor Consortium

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Sri Gururangan, MD, Study Chair, Duke University


Verification Date

October 2009