Status:
TERMINATED
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Eligibility:
All Genders
1-25 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose (MTD) of dasatinib when given immediately following ifosfamide, carboplatin, and etoposide phosphate (D-ICE) as a re-induction regimen i...
Eligibility Criteria
Inclusion
- 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 pediatric phase I studies of dasatinib or the phase I portion of this study
- Radiographically measurable disease (Phase II)
- Measurable disease is not required for patients who are enrolled in the phase I portion of this study
- No bone marrow involvement (Phase I)
- Patients with bone marrow involvement are eligible for the phase II portion of this study provided they are not known to be refractory to red cell or platelet transfusions
- PATIENT CHARACTERISTICS:
- Lansky performance status (PS) 50-100% (patients 1-16 years of age) or Karnofsky PS 50-100% (patients \> 16 years of age)
- Life expectancy ≥ 8 weeks
- ANC \> 1,000/μL
- Platelet count \> 75,000/μL
- Creatinine clearance or GFR ≥ 70 mL/min OR creatinine \< 1.5 times upper limit of normal (ULN)
- Bilirubin \< 1.5 times ULN for age
- SGOT or SGPT \< 2.5 times ULN for age (\< 5 times ULN if liver involvement by tumor)
- Ejection fraction normal by MUGA OR shortening fraction \> 28%
- No evidence of cardiac arrhythmias requiring therapy
- Corrected QTc interval \< 450 msecs
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to comply with the safety monitoring requirements of this study
- No uncontrolled infection
- No swallowing dysfunction that would preclude oral medication intake
- Gastric or jejunal tube allowed provided it is functioning
- No history of significant bleeding disorder unrelated to cancer, including the following:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- Acquired bleeding disorder diagnosed within the past year (e.g., acquired anti-factor VIII antibodies)
- Ongoing or recent (within the past 3 months) significant gastrointestinal bleeding
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- At least 7 days since prior and no concurrent drugs known to cause Torsades de Pointes, including the following:
- Procainamide or disopyramide
- Amiodarone, sotalol, ibutilide, or dofetilide
- Erythromycin or clarithromycin
- Chlorpromazine, haloperidol, mesoridazine, or thioridazine
- Bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, or lidoflazine
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea-containing therapy)
- At least 3 months since prior ifosfamide, carboplatin, and/or etoposide phosphate in the exact combination and dosage as administered in this study
- More than 7 days since prior filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-11
- More than 14 days since prior pegfilgrastim
- More than 30 days since prior epoetin alfa
- No prior cranial-spinal irradiation at doses \> 2,400 cGy
- No prior radiotherapy, including total-body irradiation, to \> 50% of the bone marrow space
- No other concurrent investigational drugs or anticancer agents
- No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, felbamate, primdone, oxcarbazepine, or carbamazepine)
- No concurrent anti-thrombotic or anti-platelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, ibuprofen, or other NSAIDs)
- No concurrent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, or voriconazole)
- No concurrent highly active antiretroviral therapy for HIV-positive patients
- No concurrent St. John's wort
- No IV bisphosphonates during the first 8 weeks of dasatinib therapy
Exclusion
Key Trial Info
Start Date :
September 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00788125
Start Date
September 3 2008
End Date
July 30 2022
Last Update
July 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope Medical Center
Duarte, California, United States, 91010-3000