Eligibility*
(inclusion criteria) |
1 Patients must be greater than or equal to 18 yrs of age with histologically confirmed melanoma tumor with wild type p53 and measurable S100B by immunohistochemistry.
2 Patients must have measurable disease, defined as at least one lesion that can be accurately measured (and biopsy obtained) in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan. See section 11.2 for evaluation of measurable disease.
3 Patients must have been evaluated for potentially curative, if possible, curative resection. There are no limits on the number of prior chemotherapeutic regimens as long as other criteria are satisfied.
4 Life expectancy of greater than 12 weeks. 5 ECOG performance status 0-2. 6 Patients must have normal organ and marrow function as defined below:
* leukocytes greater than or equal to 3,000/mcL * absolute neutrophil count greater than or equal to 1,500/mcL * platelets greater than or equal to 80,000/mcL * hemoglobin greater than or equal to 8 g/dL * total bilirubin less than or equal to 1.5 x normal institutional limits * AST(SGOT)/ALT(SGPT) less than or equal to 2.5 × institutional upper limit of normal * creatinine less than or equal to 1.5X normal institutional limits * creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
7 The potential of pentamidine for clinically significant drug interactions involving the CYP isozymes is known. Pentamidine is a CYP450: 2C19 substrate. Efforts should be made to switch patients from known CYP450 2C19 inhibitors or inducers
8 Pentamidine has not been adequately studied in pregnant women. For this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female protocol subject become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
9 Ability to take oral medications on a regular basis.
10 Ability to understand and the willingness to sign a written informed consent.
(exclusion criteria)
1 Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
2 Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days.
3 Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, zoledronic acid).
4 Patients with symptomatic (seizures, headache relatable to tumor, presence of neurologic deficits attributable to tumor) brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with stable (more than 4 weeks since prior treatment with local therapy) lesions by CT or MRI NOT requiring maintenance steroid treatment are eligible.
5 History of allergic reactions attributed to pentamidine
6 Mean QTc greater than 470 msec (with Bazett¿s correction) in screening electrocardiogram or history of familial long QT syndrome.
7 Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart.
8 Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
9 Pregnant women are excluded from this study because the effects of pentamidine on the fetus are not well documented.
10 HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pentamidine. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
|
Email this Page
Print this Page 
