Clinical trial · Interventional
Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
Phase I Trial and Pharmacokinetic Study of Temozolomide and O6-Benzylguanine in Childhood Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Childhood Germ Cell Tumor | Childhood Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor refractory to standard therapy and for which no potentially curative therapy exists, including, but not limited to: * Rhabdomyosarcoma and other soft tissue sarcomas * Ewing's family of tumors * Osteosarcoma * Neuroblastoma * Wilms' tumor * Hepatic tumors * Germ cell tumors * Primary brain tumor * Histological confirmation may be waived for brainstem or optic gliomas * Measurable or evaluable disease * Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery PATIENT CHARACTERISTICS: Age: * 21 and under Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Absolute granulocyte count greater than 1,500/mm\^3 * Hemoglobin greater than 8 g/dL * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin normal * SGPT less than 2 times upper limit of normal * No significant hepatic dysfunction Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No significant cardiac dysfunction Pulmonary: * No significant pulmonary dysfunction Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow capsules * No significant unrelated systemic illness that would preclude study (e.g., serious infections or organ dysfunction) * No prior hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G- CSF\], sargramostim \[GM-CSF\], or epoetin alfa) * At least 4 months since prior myeloablative therapy requiring bone marrow or stem cell transplantation * No concurrent anticancer immunotherapy Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered * Prior temozolomide allowed provided not administered within past 3 months, no severe toxicities experienced during prior course, and not given in combination with other agents designed to inactivate alanine-glyoxylate aminotransferase * No other concurrent investigational or standard anticancer chemotherapy Endocrine therapy: * Concurrent corticosteroids for control of brain tumor-associated edema allowed provided on stable or decreasing dose for at least 1 week prior to study Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior limited-field radiotherapy * At least 4 months since prior craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis * Recovered from prior radiotherapy * No concurrent anticancer radiotherapy Surgery: * See Disease Characteristics Other: * At least 4 weeks since other prior investigational therapy and recovered * No other concurrent anticancer investigational agents
References
Publications (2)
- RESULTMeany HJ, Warren KE, Fox E, Cole DE, Aikin AA, Balis FM. Pharmacokinetics of temozolomide administered in combination with O6-benzylguanine in children and adolescents with refractory solid tumors. Cancer Chemother Pharmacol. 2009 Dec;65(1):137-42. doi: 10.1007/s00280-009-1015-8. Epub 2009 May 9. PMID 19430790
- RESULTWarren KE, Aikin AA, Libucha M, Widemann BC, Fox E, Packer RJ, Balis FM. Phase I study of O6-benzylguanine and temozolomide administered daily for 5 days to pediatric patients with solid tumors. J Clin Oncol. 2005 Oct 20;23(30):7646-53. doi: 10.1200/JCO.2005.02.0024. PMID 16234526