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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
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: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| 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:
Contacts and Locations
Show 148 Study Locations| Study Chair: | Philip P. Breitfeld, MD | Duke Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00025363 History of Changes |
| Other Study ID Numbers: | CDR0000068954, COG-ARST0121 |
| Study First Received: | October 11, 2001 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
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recurrent childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma previously treated childhood rhabdomyosarcoma |
|
Rhabdomyosarcoma Sarcoma Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Cyclophosphamide Ifosfamide Isophosphamide mustard Irinotecan Tirapazamine Doxorubicin Etoposide Vincristine |
Camptothecin Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic |