Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or R… (NCT00788125) | Clinical Trial Compass
TerminatedPhase 1/2
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
Stopped: Terminated early due a shift in resources after lackluster performance of the drug.
United States7 participantsStarted 2008-09-03
Plain-language summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with ifosfamide, carboplatin, and etoposide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of dasatinib when given together with ifosfamide, carboplatin, and etoposide and to see how well they work in treating young patients with metastatic or recurrent malignant solid tumors.
Who can participate
Age range1 Year – 25 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed malignant solid tumor that did not respond to or relapsed after standard first-line chemotherapy or other antineoplastic therapy (if the standard therapy for the tumor is generally recognized to be beneficial)
* Must have been initially diagnosed with malignancy prior to 25 years of age
* Radiographic, nuclear image, or biopsy confirmation of disease within the past 4 weeks
* Meets one of the following criteria:
* Phase I: Relapsed/refractory malignant solid tumor (excluding CNS tumors)
* Patients with recurrent or metastatic disease that was completely resected just prior to study entry are eligible
* Phase II: Patients are stratified according to one of the following diagnoses:
* Stratum A: Relapsed sarcoma (rhabdomyosarcoma, osteosarcoma, or Ewing sarcoma)
* Stratum B: Other relapsed solid tumors, including any of the following:
* Other soft tissue sarcomas
* Kidney tumors
* Lymphoma
* CNS tumors\*
* Other solid tumors (neuroblastoma, gonadal and germ cell tumors, liver tumors, or miscellaneous tumors)
* Stratum C: Newly diagnosed, poor-risk metastatic sarcoma consisting of unresectable pulmonary metastases (≥ 6 nodules) and/or disease involving multiple bones or other organs NOTE: \*Patients with recurrent primary CNS tumors are eligible for the phase II portion of this study provided there are no significant intratumoral bleeding toxicities seen in either COG p…