0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma

Phase 2

Terminated

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 phase II trial is studying how well pentamidine works in treating patients with relapsed or refractory melanoma.

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.

Secondary

* To observe the effect of this drug on the expression of S100B and p21 in tumor biopsy samples.

* To observe the effect of this drug on S100B detectable in serum.

* To observe the time to progression in these patients.

* To assess the toxicities associated with the administration of this drug in these patients.

OUTLINE: Patients receive pentamidine IV over 2 hours 5 days a week for 2 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative laboratory studies. Samples are assessed for p53 status and S100B, p53, and p21 expression by immunohistochemistry, polymerase chain reaction, western blotting, luminescence assay, and ELISA.

After completion of study treatment, patients are followed for 30 days.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Pentamidine	pentamidine	-

Primary Outcome Measures

Name	Time	Method
Response Rate in Patients Treated With Pentamidine	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	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 Outcome Measures

Name	Time	Method
Number of Participants With p21 and S100B Expression in Accessible Tumor Biopsies Post Pentamidine Exposure	Day 12 Cycle 1	Core needle tumor biopsy - at Day 12 at first cycle of treatment
Expression of S100B Pre Pentamidine Exposure	Pre-Study	Serum for S100B
Number of Participants With Both p21 and S100B Expression in Accessible Tumor Biopsies Pre Pentamidine Exposure in Cycle 1	Pre-Study, an average of 12 days	Core Needle Tumor Biopsy
Expression of S100B	Cycle 1 Day 8, Cycle 1 Day 12, Cycle 2 Day 8, Cycle 2 Day 12	Serum for S100B level
Number of Participants With Serious and Non Serious Adverse Events	Up to 6 months	Metabolic Panel, Physical Exam, Vitals
Time to Progression	Every 8 weeks, assesed up to 6 months	Radiologic intervention using RECIST (x-ray, CT, MRI) 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; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.