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Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025363
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma.


Condition Intervention Phase
Sarcoma
Biological: filgrastim
Biological: sargramostim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: tirapazamine
Drug: vincristine sulfate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Response at week 6 of investigational window therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Blood metabolite SN-38 levels [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma

    • First relapse or first occurrence of disease progression
  • Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:

    • Unfavorable risk defined by any of the following:

      • Embryonal histology with stage I or group I at initial diagnosis with distant recurrence or with local or regional recurrence after prior cyclophosphamide
      • Embryonal histology with initial stage II, III, or IV or group II, III, or IV with any relapse pattern
      • Alveolar histology with any stage or group at initial diagnosis
    • At least unidimensionally measurable disease
    • No prior irinotecan
    • Bone marrow must not be only site of relapse OR
  • Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:

    • Either no measurable disease OR patient received prior irinotecan
    • Bone marrow as only site of relapse allowed OR
  • Favorable-risk patients meeting the following criteria:

    • Initial botryoid histology (any stage, any group, or any pattern of relapse)
    • Embryonal histology if either stage I or group I (with either local or regional recurrence)
    • No prior cyclophosphamide
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • Under 21 at time of initial diagnosis

Performance status:

  • ECOG 0-2
  • Zubrod 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count at least 750/mm^3
  • Platelet count at least 75,000/mm^3 (transfusion independent)
  • Hemoglobin at least 10.0 g/dL (red blood cell transfusion allowed)

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • 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

Cardiovascular:

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction at least 50% by MUGA
  • No prior ischemic heart disease

Other:

  • Seizure disorder allowed if well controlled by anticonvulsants
  • No CNS toxicity greater than grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior myeloablative therapy with stem cell transplantation
  • At least 1 week since prior antineoplastic biologic agent
  • At least 1 week since prior growth factor(s)
  • Recovered from prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • See Disease Characteristics
  • See Biologic therapy
  • No more than 1 prior chemotherapy regimen
  • No prior doxorubicin or daunorubicin
  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • Concurrent corticosteroid therapy allowed

Radiotherapy:

  • At least 2 weeks since prior small-port radiotherapy.
  • At least 6 months since prior radiotherapy to 50% or more of pelvis
  • At least 6 weeks since other prior substantial radiotherapy to bone marrow
  • Recovered from prior radiotherapy
  • Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
  • No concurrent intensity-modulated radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025363

  Show 148 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Philip P. Breitfeld, MD Duke University
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068954, COG-ARST0121
Study First Received: October 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00025363     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma

Study placed in the following topic categories:
Immunologic Factors
Irinotecan
Cyclophosphamide
Etoposide phosphate
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Soft Tissue Sarcomas
Etoposide
Alkylating Agents
Rhabdomyosarcoma
Vincristine
Rhabdomyosarcoma, Childhood
Antimitotic Agents
Immunosuppressive Agents
Doxorubicin
Recurrence
Camptothecin
Ifosfamide
Malignant Mesenchymal Tumor
Radiation-Sensitizing Agents
Tubulin Modulators
Sarcoma
Tirapazamine
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Therapeutic Uses
Alkylating Agents
Rhabdomyosarcoma
Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Doxorubicin
Camptothecin
Pharmacologic Actions
Ifosfamide
Neoplasms
Radiation-Sensitizing Agents
Tubulin Modulators
Sarcoma
Myeloablative Agonists
Tirapazamine
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on September 02, 2009