Status:
TERMINATED
0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 phas...
Detailed Description
OBJECTIVES: Primary * To determine the response rate in patients with relapsed or refractory melanoma that expresses wild-type p53 and S100 calcium binding protein B (S100B) treated with pentamidine...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00729807
Start Date
July 1 2008
End Date
November 1 2012
Last Update
August 16 2019
Active Locations (1)
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1
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201