Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003745
First received: November 1, 1999
Last updated: February 4, 2013
Last verified: April 2003
  Purpose

Phase II trial to study the effectiveness of topotecan in treating children who have recurrent, relapsed, or refractory sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.


Condition Intervention Phase
Sarcoma
Drug: topotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors

Resource links provided by NLM:


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

Enrollment: 125
Study Start Date: May 1999
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive topotecan IV continuously on days 1-21. Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression.
Drug: topotecan hydrochloride

Detailed Description:

OBJECTIVES:

I. Determine the response rate in children with recurrent or refractory brain tumors, sarcomas, or neuroblastomas treated with topotecan. (Brain tumor and neuroblastoma strata closed to accrual effective 07/02/2001) II. Assess the toxicity of this regimen in a larger group of patients treated at the currently defined maximum tolerated dose.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV continuously on days 1-21. Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy that is relapsed or refractory to conventional therapy at original diagnosis including:

    • Brain tumors

      • Gliomas or astrocytomas
      • Medulloblastomas or primitive neuroectodermal tumor (PNET) in CNS
      • (Brain tumor stratum closed to accrual effective 07/02/2001)
    • Sarcomas

      • Soft tissue sarcoma (undifferentiated sarcoma, embryonal or alveolar rhabdomyosarcoma (RMS), or non-RMS soft tissue sarcoma)
      • Osteosarcoma
      • Ewing's sarcoma/peripheral PNET tumors
    • Neuroblastoma

      • (Neuroblastoma stratum closed to accrual effective 07/02/2001)
  • Histology requirement waived for brain stem tumors (Brain tumor stratum closed to accrual effective 07/02/2001)
  • Measurable disease documented by clinical, radiographic, or histologic criteria
  • Lesions in previously irradiated fields may be used to assess tumor response if there has been evidence of subsequent tumor growth in those fields
  • No bone marrow metastases with granulocytopenia and/or thrombocytopenia

PATIENT CHARACTERISTICS:

Age:

  • 30 days to 21 years at diagnosis

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 2 months

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm3
  • Hemoglobin at least 10.0 g/dL (may receive RBC transfusions)
  • Platelet count at least 100,000/mm3 (50,000/mm3 if post bone marrow transplantation) (transfusion independent)

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT or SGPT less than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Neurologic:

  • No greater than grade 2 CNS toxicity OR
  • Stable CNS status for brain tumors (Brain tumor stratum closed to accrual effective 07/02/2001)
  • Seizure disorders allowed if well-controlled with anticonvulsants

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 months since prior bone marrow transplantation and recovered
  • At least 2 weeks since prior cytokines and recovered
  • No concurrent filgrastim (G-CSF) or other cytokines
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
  • No prior topotecan or other camptothecins
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids for CNS tumors with increased intracranial pressure allowed (Brain tumor stratum closed to accrual effective 07/02/2001)

Radiotherapy:

  • At least 2 months since prior craniospinal radiotherapy or radiotherapy to more than 50% of the bone marrow and recovered
  • Concurrent radiotherapy to localized painful lesions allowed provided that at least 1 measurable lesion is not irradiated

Other:

  • Recovered from any other prior therapy
  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: NCT00003745

  Show 235 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Douglas Hawkins, MD Seattle Children's Hospital
  More Information

Additional Information:
Publications:
Bradfield S, Hawkins DS, Whitlock J, et al.: Phase II study of 21 day continuous intravenous infusion (CIVI) topotecan for recurrent pediatric solid tumors: a Children's Oncology Group Study (COG A09713). [Abstract] J Clin Oncol 23 (Suppl 16): A-8523, 805s, 2005.

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003745     History of Changes
Other Study ID Numbers: NCI-2012-01841, COG-A09713, CCG-A09713, CCG-09713, CDR0000066864
Study First Received: November 1, 1999
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent childhood rhabdomyosarcoma
recurrent osteosarcoma
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
recurrent childhood soft tissue sarcoma
extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014