Clinical Trials /

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

NCT00729807

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title:Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
  • Official Title:Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints

Clinical Trial IDs

  • ORG STUDY ID: CDR0000602047
  • SECONDARY ID: MSGCC-0794GCC
  • SECONDARY ID: MSGCC-H-2987
  • SECONDARY ID: CINJ-090803
  • SECONDARY ID: 0220090161
  • NCT ID: NCT00729807

Trial Conditions

  • Melanoma (Skin)

Trial Interventions

DrugSynonymsArms
pentamidine

Trial Purpose

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 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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

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:

- ECOG performance status 0-2

- Life expectancy > 12 weeks

- WBC ≥ 3,000/mcL

- ANC ≥ 1,500/mcL

- Platelet count ≥ 80,000/mcL

- Hemoglobin ≥ 8 g/dL

- Total bilirubin ≤ 1.5 times normal

- AST and 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 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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical response
Time Frame:
Safety Issue:No
Description:

Secondary Outcome Measures

Measure:Wild-type p53 and S100B status at baseline
Time Frame:
Safety Issue:No
Description:
Measure:Pre- and post-treatment changes in the concentration of S100B and p21 in tumor biopsy samples
Time Frame:
Safety Issue:No
Description:
Measure:Serial levels of serum S100B
Time Frame:
Safety Issue:No
Description:

Trial Keywords

  • recurrent melanoma