Pentamidine in Treating Patients With Relapsed or Refractory Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00729807
First received: August 7, 2008
Last updated: December 16, 2009
Last verified: October 2008
  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.


Condition Intervention Phase
Melanoma (Skin)
Drug: pentamidine
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: western blotting
Other: bioluminescence
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wild-type p53 and S100B status at baseline [ Designated as safety issue: No ]
  • Pre- and post-treatment changes in the concentration of S100B and p21 in tumor biopsy samples [ Designated as safety issue: No ]
  • Serial levels of serum S100B [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: July 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729807

Locations
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit    800-888-8823      
Sponsors and Collaborators
University of Maryland Greenebaum Cancer Center
Investigators
Principal Investigator: Edward A. Sausville, MD, PhD University of Maryland Greenebaum Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Edward A. Sausville, Greenebaum Cancer Center at University of Maryland Medical Center
ClinicalTrials.gov Identifier: NCT00729807     History of Changes
Other Study ID Numbers: CDR0000602047, MSGCC-0794GCC, MSGCC-H-2987, CINJ-090803, 0220090161
Study First Received: August 7, 2008
Last Updated: December 16, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Pentamidine
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on October 22, 2014