| ID | Type | Description | Link |
|---|---|---|---|
| 05-C-0239 | |||
| NCI-P6672 | |||
| CDR0000462620 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving talabostat together with temozolomide or carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of talabostat when given together with temozolomide or carboplatin in treating young patients with relapsed or refractory brain tumors or other solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of talabostat. Patients are stratified according to tumor histology and prior therapy.
Based on stratification, patients receive either oral temozolomide on days 1-5 or carboplatin IV over 30 minutes on days 1-2. Patients also receive oral talabostat on days 7-20. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. (Closed to accrual as of 5/25/2009)
Cohorts of 2-6 patients receive escalating doses of talabostat until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or < 4 of 12 patients experience dose-limiting toxicity during the first course of therapy.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| talabostat mesylate | Drug | |||
| temozolomide | Drug | |||
| pharmacological study | Other |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumors, including, but not limited to, any of the following:
Rhabdomyosarcoma and other soft tissue sarcomas
Ewing's sarcoma family of tumors
Osteosarcoma
Neuroblastoma
Wilms' tumor
Hepatic tumors
Germ cell tumors
Primary brain tumors
In patients with brainstem or optic gliomas, requirement for histological confirmation can be waived if biopsy was not performed
Patients with brain tumors must be on stable or tapering dose of corticosteroids for 7 days prior to study entry
Measurable or evaluable disease
Relapsed or failed to respond to frontline curative therapy, including any of the following:
No other potentially curative treatment options available
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Absolute neutrophil count ≥ 1,500/mm^3
Hemoglobin ≥ 8 mg/dL
Platelet count ≥ 100,000/mm^3 (platelet transfusion independent)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGPT ≤ 2.5 times ULN
Creatinine clearance ≥ 60 mL/min OR age-adjusted creatinine* as follows:
Patients with history of seizures eligible if seizures controlled by anticonvulsants
No clinically significant, unrelated systemic illness, including either of the following:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No generalized pitting peripheral edema
No sensitivity to valine-proline boronic acid
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Meany, MD | National Cancer Institute (NCI) | Study Chair |
| Elizabeth Fox, MD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | 20892-1182 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20460632 | Result | Meany H, Balis FM, Aikin A, Whitcomb P, Murphy RF, Steinberg SM, Widemann BC, Fox E. Pediatric phase I trial design using maximum target inhibition as the primary endpoint. J Natl Cancer Inst. 2010 Jun 16;102(12):909-12. doi: 10.1093/jnci/djq174. Epub 2010 May 11. |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D007680 | Kidney Neoplasms |
| D008113 | Liver Neoplasms |
| D009447 | Neuroblastoma |
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D012516 | Osteosarcoma |
| D009396 | Wilms Tumor |
| D001254 | Astrocytoma |
| C531673 | Familial ependymoma |
| D008527 | Medulloblastoma |
| D018335 | Rhabdoid Tumor |
| D016545 | Choroid Plexus Neoplasms |
| D009837 | Oligodendroglioma |
| D020339 | Optic Nerve Glioma |
| C562841 | Ovarian Germ Cell Cancer |
| D013736 | Testicular Neoplasms |
| D013724 | Teratoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005910 | Glioma |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D013733 | Testicular Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C477478 | PT-100 dipeptide |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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