Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors

NCT00303940 | Completed Phase 1

• 4 other identifiers: 05023905-C-0239NCI-P6672CDR0000462620
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific; recurrent childhood rhabdomyosarcoma; recurrent childhood soft tissue sarcoma; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent osteosarcoma; recurrent neuroblastoma; recurrent Wilms tumor and other childhood kidney tumors; recurrent childhood malignant germ cell tumor; recurrent childhood liver cancer; recurrent childhood brain stem glioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood ependymoma; recurrent childhood medulloblastoma; recurrent childhood supratentorial primitive neuroectodermal tumor; childhood atypical teratoid/rhabdoid tumor; childhood low-grade cerebral astrocytoma; childhood high-grade cerebral astrocytoma; childhood choroid plexus tumor; childhood craniopharyngioma; childhood infratentorial ependymoma; childhood supratentorial ependymoma; childhood oligodendroglioma; recurrent childhood visual pathway and hypothalamic glioma; recurrent childhood brain tumor; childhood central nervous system germ cell tumor; childhood grade I meningioma; childhood grade II meningioma; childhood grade III meningioma; childhood malignant ovarian germ cell tumor; childhood malignant testicular germ cell tumor; childhood teratoma

Interventions

carboplatin DRUG

talabostat mesylate DRUG

temozolomide DRUG

pharmacological study OTHER

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 brainstem gliomas that did not respond to therapy but that are without radiographic evidence of disease progression must have clinical evidence of progression * 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: * Surgery * Radiotherapy * Chemotherapy * Combination of modalities * 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: * No more than 0.8 mg/dL (for patients ≤ 5 years of age) * No more than 1.0 mg/dL (for patients 6 to 10 years of age) * No more than 1.2 mg/dL (for patients 11 to 15 years of age) * No more than 1.5 mg/dL (for patients \> 15 years of age) NOTE: \*For patients receiving carboplatin a nuclear glomerular filtration rate study, 24-hour urine collection, and serum creatinine for estimation of creatinine clearance is required if under 15 years of age OR serum creatinine and weight for estimation of creatinine clearance is required if 15-18 years of age * Patients with history of seizures eligible if seizures controlled by anticonvulsants * No clinically significant, unrelated systemic illness, including either of the following: * Serious infections * Hepatic, renal, or other organ dysfunction that would preclude study treatment * 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: * See Disease Characteristics * Recovered to ≤ grade 1 from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study entry * Any number of prior chemotherapy regimens allowed * Prior temozolomide or carboplatin as frontline therapy or in the adjuvant setting allowed provided patient did not experience severe toxicities related to the drug and tumor progressed during this therapy * At least 3 weeks since last dose of all myelosuppressive chemotherapy * At least 7 days since last dose of anticancer biologic agents (e.g., retinoids) * At least 30 days since prior investigational agents * At least 4 weeks since prior radiotherapy to \> 25% of marrow-containing bones (pelvis, spine, or skull) (2 weeks for palliative \[limited-port\] radiotherapy) * At least 2 months since prior autologous stem cell transplantation and recovered * At least 1 week since prior filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa * At least 2 weeks since prior pegfilgrastim * No history of allogeneic stem cell transplantation * No other concurrent anticancer chemotherapy, radiation therapy, or immunotherapy * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

• 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.

  PMID: 20460632 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Kidney Neoplasms; Liver Neoplasms; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Osteosarcoma; Wilms Tumor; Astrocytoma; Familial ependymoma; Medulloblastoma; Rhabdoid Tumor; Choroid Plexus Neoplasms; Oligodendroglioma; Optic Nerve Glioma; Ovarian Germ Cell Cancer; Testicular Neoplasms; Teratoma

Interventions

Carboplatin; PT-100 dipeptide; Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Holly Meany, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

• Elizabeth Fox, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: December 1, 2005
• Study Completion: February 1, 2010
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)