New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00001335 |
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Recruitment Status :
Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ewing's Sarcoma Neuroblastoma Rhabdomyosarcoma | Drug: ADR-529 Drug: Topotecan Drug: G-CSF | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 90 participants |
| Primary Purpose: | Treatment |
| Official Title: | New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma |
| Study Start Date : | April 1993 |
| Study Completion Date : | January 2002 |
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
The patient must fall into one of the following diagnostic categories:
Ewing's sarcoma family of tumors (ESF): Includes Ewing's sarcoma (classic, atypical, extra-osseous), primitive sarcoma of bone, ectomesenchymoma, or peripheral primitive neuroectodermal tumor (peripheral neuroepithelioma).
Rhabdomyosarcoma: The patient must have either
High-risk arm: Metastatic disease at diagnosis (any site, any histology);
OR
Moderate-risk arm: Incompletely resected ( Clinical Group III) Stage II tumors and ALL stage III tumors (regardless of degree of surgical resection).
Neuroblastoma: Any patient with metastatic disease at diagnosis (POG stage D or Evans' stage IV); or, patients with loco-regional metastatic disease (POG stage C) or tumor infiltrating across the midline (Evans' stage III) IF they have an elevated serum ferritin (greater than 142 ng/ml), an amplified N-myc copy number (greater than 10 copies on Southern analysis), or a DNA index of greater than 1.1.
The patient must not have been previously treated with chemotherapy or radiation therapy.
Patients must be greater than or equal to 1 year of age but less than or equal to 25 years of age. Patients weight must be greater than or equal to 15 kg.
The patient (or his/her guardian if less than 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected.
Potentially fertile female patients must have a documented negative urine or serum pregnancy test.
Patients must have a documented negative HIV serologic evaluation (Western Blot and/or ELISA).
Patients must not have abnormal cardiac function (left ventricular ejection fraction less than 45% as measured by gated equilibrium radionuclide angiography [MUGA scan] and confirmed by echocardiography).
Patients must not have impaired renal function (serum creatinine greater than or equal to twice the upper limit of normal for age).
Patients with a total bilirubin of greater than 4.0 mg/dl (or a direct bilirubin of greater than 2.0 mg/dl) or SGOT/SGPT greater than five times the upper limits of normal (NOT on the basis of hepatic involvement by tumor) will be excluded.
Patients with a second malignancy following previous therapy will be excluded.
Patients previously treated with chemotherapy or radiation therapy (other than limited, emergency radiation therapy) will be excluded.
Patients who are HIV-infected will be excluced.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001335
| United States, Maryland | |
| National Cancer Institute (NCI) | |
| Bethesda, Maryland, United States, 20892 | |
| ClinicalTrials.gov Identifier: | NCT00001335 History of Changes |
| Other Study ID Numbers: |
930125 93-C-0125 |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | March 4, 2008 |
| Last Verified: | January 2002 |
Keywords provided by National Institutes of Health Clinical Center (CC):
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Peripheral Stem Cell Transfusion Up-Front Phase II Window Dose-Intensive Vincristine Dose-Intensive Doxorubicin |
Dose-Intensive Cyclophosphamide ADR-529 for Cardioprotection BID Radiation Therapy for Local Control |
Additional relevant MeSH terms:
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Sarcoma Neuroblastoma Rhabdomyosarcoma Sarcoma, Ewing Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Myosarcoma |
Neoplasms, Muscle Tissue Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Topotecan Dexrazoxane Razoxane Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cardiotonic Agents Topoisomerase II Inhibitors Protective Agents |