Clinical trial · Interventional
Irinotecan and Selenium in Treating Patients With Advanced Solid Tumors
A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced 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, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with selenium may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| selenium | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor
* Metastatic or unresectable disease
* Standard curative or palliative treatments do not exist or are no longer effective OR treatment with single-agent irinotecan does not constitute a reasonable treatment option
* No known untreated or progressive brain metastases
* Previously treated brain metastases allowed provided all of the following are true:
* No significant neurological deficit
* No requirement for anti-epileptic medications
* Disease stable by brain CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 12 weeks
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin normal
* AST and ALT ≤ 3 times upper limit of normal
* Albumin ≥ 3.0 g/dL
* No Gilbert's disease
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No clinically significant cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to receive oral medications
* No active inflammatory bowel disease or chronic diarrhea
* No known HIV positivity
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)
Endocrine therapy
* Not specified
Radiotherapy
* At least 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent Hypericum perforatum (St. John's wort)References
Publications (1)
- RESULTFakih MG, Pendyala L, Brady W, Smith PF, Ross ME, Creaven PJ, Badmaev V, Prey JD, Rustum YM. A Phase I and pharmacokinetic study of selenomethionine in combination with a fixed dose of irinotecan in solid tumors. Cancer Chemother Pharmacol. 2008 Aug;62(3):499-508. doi: 10.1007/s00280-007-0631-4. Epub 2007 Nov 8. PMID 17989978