Clinical trial · Interventional
Everolimus in Treating Patients With Stage IV Melanoma
Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma
NCT00098553CI-TRIAL-00022897completedPhase 2ClinicalTrials.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: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- everolimus
- description
- Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.
- interventionNames
- Drug: everolimus
Primary outcomes (1)
- measure
- Proportion of patients with progression-free disease at 16 weeks
- timeFrame
- at 16 weeks
Secondary outcomes (4)
- measure
- Median overall survival
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma for which no known standard or potentially curative therapy exists or has been proven to extend life expectancy * Stage IV disease * Measurable disease * At least 1 lesion ≥ 20 mm by CT scan or MRI OR ≥ 10 mm by spiral CT scan * No intracranial disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * No bleeding diathesis Hepatic * AST ≤ 3 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 ULN * INR ≤ 1.5 Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to refrain from foods high in fat content * No uncontrolled infection * No immunosuppression from any cause (e.g., known HIV infection) * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only * No other severe condition that would preclude study participation or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy or biologic therapy Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior sirolimus or its analogues for any indication * No other concurrent chemotherapy Endocrine therapy * No concurrent steroids Radiotherapy * More than 4 weeks since prior radiotherapy to head and neck area * More than 4 weeks since prior radiosurgery * No prior radiotherapy to \> 30% of bone marrow * No concurrent radiotherapy Surgery * Not specified Other * At least 1 week since prior and no concurrent CYP3A4 inducers * No concurrent warfarin * No concurrent cytotoxic agents * No other concurrent experimental drugs * No other concurrent immunosuppressive therapy
References
Publications (3)
- RESULTRao RD, Allred JB, Windschitl HE, et al.: N0377: results of NCCTG phase II trial of the mTOR inhibitor RAD-001 in metastatic melanoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-8530, 479s, 2007.
- RESULTRao RD, Windschitl HE, Allred JB, et al.: Phase II trial of the mTOR inhibitor everolimus (RAD-001) in metastatic melanoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-8043, 463s, 2006.
- DERIVEDVera Aguilera J, Rao RD, Allred JB, Suman VJ, Windschitl HE, Kaur JS, Maples WJ, Lowe VJ, Creagan ET, Erickson LA, Markovic S. Phase II Study of Everolimus in Metastatic Malignant Melanoma (NCCTG-N0377, Alliance). Oncologist. 2018 Aug;23(8):887-e94. doi: 10.1634/theoncologist.2018-0100. Epub 2018 Apr 17. PMID 29666297