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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025363 |
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 |
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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 |
Estimated Enrollment: | 150 |
Study Start Date: | November 2001 |
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:
Unfavorable risk defined by any of the following:
Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:
Favorable-risk patients meeting the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Philip P. Breitfeld, MD | Duke University |
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 |
recurrent childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma previously treated childhood rhabdomyosarcoma |
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 |
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 |