Clinical trial · Interventional
0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints
NCT00729807CI-TRIAL-00040094terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed at the suggestion of DSMB prior to obtaining target enrollment
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with relapsed or refractory 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 |
|---|---|---|---|
| pentamidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pentamidine
- interventionNames
- Drug: pentamidine
Primary outcomes (1)
- measure
- Response Rate in Patients Treated With Pentamidine
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum of the longest diameter since the treatment started. (Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, J., Van Glabbeke, M., van Oosterom, A.T., Christian, M.C., Gwyther, S.G. (2000) J Natl Cancer Inst 92, 205-16)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Relapsed or refractory disease * Tumor expresses wild-type p53 * Measurable S100B by immunohistochemistry * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan * Tumor amenable to biopsy * Must have been evaluated for potentially curative resection * No unstable or symptomatic brain metastases (e.g., seizures, headache related to tumor, or presence of neurologic deficits attributable to tumor) * Patients with stable brain metastases (by CT scan or MRI) are eligible provided they were treated with local therapy \> 4 weeks ago AND do not require maintenance steroid treatment PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy \> 12 weeks * White Blood Cell count (WBC) ≥ 3,000/mcL * Absolute Neutrophil Count (ANC) ≥ 1,500/mcL * Platelet count ≥ 80,000/mcL * Hemoglobin ≥ 8 g/dL * Total bilirubin ≤ 1.5 times normal * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 times normal or creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * Able to take oral medications on a regular basis * No history of allergic reactions attributed to pentamidine * Mean Corrected QT Interval (QTc) ≤ 470 msec (with Bazett's correction) on screening ECG * No history of familial long QT syndrome * Proteinuria ≤ 1 on two consecutive dipsticks taken ≥ 1 week apart * No concurrent uncontrolled illness including, but not limited to, any of the following: * Hypertension * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Renal failure * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * Any number of prior chemotherapy regimens allowed * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * More than 4 weeks since prior radiotherapy or major surgery * More than 30 days since prior participation in an investigational trial * No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, zoledronic acid) * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.