Clinical trial · Interventional
Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
- 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: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sulindac together with epirubicin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sulindac together with epirubicin works in treating patients with metastatic malignant 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| immunologic technique | Other | — | UNRESOLVED |
| sulindac | Drug | Sulindac | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg
- interventionNames
- Drug: epirubicin hydrochloride
- Drug: sulindac
- Other: immunologic technique
Primary outcomes (1)
- measure
- To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
- timeFrame
- Ongoing throughout trial
- description
- The interim analysis will study the objective response to treatment in the first cohort of 29 patients. Response will be assessed according to NCI -Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
Secondary outcomes (1)
- measure
- Toxicity according to NCI CTCAE v.3.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * Metastatic disease * Tumor block available for resistance marker analysis * Measurable or evaluable disease * No active brain metastases except for patients who have undergone successful complete excision of solitary brain metastasis PATIENT CHARACTERISTICS: * Karnofsky performance status 80-100% * ANC \> 1 x 10\^9/L * Platelet count \> 100 x 10\^9/L * Hemoglobin \> 9 g/dL * Serum bilirubin normal (except in patients with benign congenital hyperbilirubinemia) * Not pregnant or nursing * Negative pregnancy test * Normal cardiac ejection fraction, cardiac wall motion, and ECG * No active heart disease, including any of the following: * Myocardial infarction within the past year * Pericarditis * Existing hypertension requiring treatment * No other active serious medical or psychiatric disease * No prior or concurrent malignancy, other than basal cell carcinoma of the skin , or carcinoma in-situ of the cervix PRIOR CONCURRENT THERAPY: * No prior anthracycline or anthracenedione-containing chemotherapy regimen * No prior cardiac radiotherapy * No major surgery within the past 2 weeks * No participation in any clinical trial within the past 4 weeks * No other concurrent anticancer therapies * Concurrent bisphosphonates allowed in patients with bony metastases with extra-osseous measurable or evaluable lesions * No other concurrent experimental medications
References
Publications (0)
Data not yet available