Clinical trial · Interventional
Sirolimus in Treating Patients With Metastatic or Unresectable Solid Tumors
Pharmacodynamic-Guided Dose Finding Study of Rapamycin (Rapamune®, Sirolimus) in Adult Patients With Solid Tumors
NCT00368914CI-TRIAL-00003756completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in treating patients with metastatic or unresectable 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Pharmacodynamic optimal dose of sirolimus by evaluation of p70s6 kinase inhibition in peripheral blood mononuclear cells (PBMC) and normal skin
- measure
- Correlation of target tissue inhibition in tumor tissue with PMBCs and normal skin
Secondary outcomes (9)
- measure
- Pharmacokinetics
- measure
- Pharmacodynamic effects of sirolimus on tumor, normal skin, and normal oral mucosa
- measure
- Correlation of pharmacodynamic effects of sirolimus with pharmacokinetics and clinical effects
- measure
- Pharmacokinetic-pharmacodynamic and toxicodynamic relationships
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor malignancy * Metastatic or inoperable disease * Failed curative or standard palliative therapy OR no such therapy exists * Evaluable or measurable disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Tumor amenable to serial biopsies * No known brain metastases PATIENT CHARACTERISTICS: * ECOG 0-1 * Life expectancy ≥ 3 months * WBC \> 3,500/mm³ * Absolute neutrophil count \> 1,500/mm³ * Hemoglobin \> 9 g/dL * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2 mg/dL * ALT and AST ≤ 5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 5 times ULN * Triglycerides \< 2 times ULN * Total cholesterol \< 2 times ULN * Willing to undergo serial tumor biopsies and normal skin biopsies * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No immunodeficiency * No gastrointestinal tract disease resulting in an inability to take oral medication * No requirement for IV alimentation * No active peptic ulcer disease * No active infections * No other uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy * No concurrent or second malignancy within the past 5 years * No clinically significant cardiovascular disease, including any of the following: * Myocardial infarction within the past 12 months * Unstable angina * Peripheral vascular disease ≥ grade 2 * Uncontrolled congestive heart failure * Uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 170 mm Hg, diastolic BP \> 95 mm Hg) PRIOR CONCURRENT THERAPY: * Recovered from prior anticancer therapy * No unresolved chronic toxicity \> CTC grade 2 * No prior surgical procedures affecting absorption * More than 4 weeks since prior surgery except minor procedures (e.g., dental work or skin biopsy) * More than 1 month since prior participation in an investigational drug trial * More than 1 month since prior chemotherapy * No concurrent use of any of the following: * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Phenobarbital * Cyclosporine * Clarithromycin * Diltiazen * Clotrimazole * Ketoconazole * Fluconazole * Hypericum perforatum (St. John's wort) * Cimetidine * Grapefruit juice * No concurrent immunosuppressants * No other concurrent investigational or commercial agents or therapies for this malignancy
References
Publications (1)
- RESULTJimeno A, Rudek MA, Kulesza P, Ma WW, Wheelhouse J, Howard A, Khan Y, Zhao M, Jacene H, Messersmith WA, Laheru D, Donehower RC, Garrett-Mayer E, Baker SD, Hidalgo M. Pharmacodynamic-guided modified continuous reassessment method-based, dose-finding study of rapamycin in adult patients with solid tumors. J Clin Oncol. 2008 Sep 1;26(25):4172-9. doi: 10.1200/JCO.2008.16.2347. PMID 18757332