Lobradimil and Carboplatin in Treating Children With Brain Tumors

This study has been completed.
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019422
First received: July 11, 2001
Last updated: August 14, 2013
Last verified: April 2003
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carboplatin
Drug: lobradimil
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 1998
Study Completion Date: April 2003
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate in patients with recurrent or refractory childhood brain tumors treated with lobradimil and carboplatin.
  • Determine the time to progression in patients treated with this regimen.
  • Assess the toxicity of this regimen in this patient population.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients are stratified according to histology (high-grade glioma vs low-grade glioma vs brainstem or visual pathway glioma vs medulloblastoma/primitive neuroectodermal tumor vs ependymoma). (Brainstem glioma stratum closed to accrual as of 12/21/2000.) (High-grade glioma stratum closed to accrual as of 01/08/2002.)

Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1 and 2. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 12, patients may receive additional courses at the discretion of the institutional investigator.

Quality of life is assessed at baseline and then every 3 courses.

Patients are followed every 3 months for 1 year or until evidence of disease progression or initiation of a new therapy.

PROJECTED ACCRUAL: A maximum of 146 patients will be accrued for this study within 2-4 years.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed childhood brain tumor that is recurrent or refractory or for which no standard chemotherapy exists

    • High-grade glioma (anaplastic astrocytoma or glioblastoma multiforme) (High-grade glioma stratum closed to accrual as of 01/08/2002)
    • Low-grade glioma
    • Medulloblastoma/primitive neuroectodermal tumor (PNET)
    • Ependymoma
    • Brainstem tumor or visual pathway glioma (with radiographic evidence only) (Brainstem glioma stratum closed to accrual as of 12/21/2000)
  • Evidence of recurrent or progressive disease after front-line therapy documented as an increase in tumor size or appearance of new lesion(s) on MRI
  • Patients who did not previously receive radiotherapy as front-line therapy are eligible at time of second recurrence if the first recurrence was treated with radiotherapy only
  • Measurable disease in at least 2 dimensions by MRI

    • Diffuse meningeal involvement not considered measurable if it is the only site of disease
  • Disease must not be limited to the meninges
  • No metastases outside of the CNS

PATIENT CHARACTERISTICS:

Age:

  • 21 and under at diagnosis

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Absolute granulocyte count at least 1,000/mm^3
  • Hemoglobin at least 8.0 g/dL (transfusion allowed)
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGPT no greater than 2.5 times ULN
  • No significant hepatic illness

Renal:

  • Creatinine within limits as defined below by age:

    • Age 5 and under: less than 1.2 mg/dL
    • Age 6 to 10: less than 1.5 mg/dL
    • Age 11 to 15: less than 1.8 mg/dL
    • Age 16 and over: less than 2.4 mg/dL

Cardiovascular:

  • No significant cardiac illness

Pulmonary:

  • No significant pulmonary illness

Other:

  • No significant systemic illness or organ dysfunction that would preclude study
  • No allergic reaction to platinum-containing compounds
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 72 hours since filgrastim (G-CSF)
  • No concurrent biologic therapy for brain tumor

Chemotherapy:

  • See Disease Characteristics
  • No prior carboplatin or lobradimil
  • No more than 1 prior chemotherapy regimen for high-grade glioma, low-grade glioma, or ependymoma
  • No more than 2 prior chemotherapy regimens for medulloblastoma/PNET
  • At least 4 weeks since prior nitrosoureas (2 weeks if also received stem cell/bone marrow rescue)
  • At least 2 weeks since any other prior myelosuppressive chemotherapy and recovered
  • No other concurrent chemotherapy for brain tumor

Endocrine therapy:

  • Concurrent corticosteroids for management of tumor-related edema allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 6 weeks since prior radiotherapy to measurable disease and recovered
  • No concurrent radiotherapy for brain tumor

Surgery:

  • No concurrent surgery except for ventriculo-peritoneal shunt placement or revision

Other:

  • At least 24 hours since prior vasodilating agents, angiotensin-converting enzyme inhibitors, calcium channel blockers, or beta-blockers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019422

  Show 236 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Katherine Warren, MD National Cancer Institute (NCI)
Study Chair: Regina Jakacki, MD Children's Hospital of Pittsburgh of UPMC
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00019422     History of Changes
Obsolete Identifiers: NCT00001690
Other Study ID Numbers: CDR0000066169, NCI-98-C-0074H, CCG-09716, ALK-01-041, NCI-T98-0011, COG-C09716
Study First Received: July 11, 2001
Last Updated: August 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood low-grade cerebral astrocytoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
untreated childhood visual pathway and hypothalamic glioma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma

Additional relevant MeSH terms:
Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014