Melanoma (Skin)Phase 2NCT00729807
0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
A Phase 2 study testing pentamidine in people with Melanoma (Skin), run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- pentamidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints
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.
Read the 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.
- Conditions
- Melanoma (Skin)
- Being tested
- pentamidine
- Keywords
- recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentamidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Pentamidine | Experimental | Not described Receives: Drug: pentamidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate in Patients Treated With Pentamidine
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)
Measured: 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
Secondary outcomes (6)
Number of Participants With Both p21 and S100B Expression in Accessible Tumor Biopsies Pre Pentamidine Exposure in Cycle 1
Core Needle Tumor Biopsy
Measured: Pre-Study, an average of 12 days
Number of Participants With p21 and S100B Expression in Accessible Tumor Biopsies Post Pentamidine Exposure
Core needle tumor biopsy - at Day 12 at first cycle of treatment
Measured: Day 12 Cycle 1
Expression of S100B Pre Pentamidine Exposure
Serum for S100B
Measured: Pre-Study
Expression of S100B
Serum for S100B level
Measured: Cycle 1 Day 8, Cycle 1 Day 12, Cycle 2 Day 8, Cycle 2 Day 12
Number of Participants With Serious and Non Serious Adverse Events
Metabolic Panel, Physical Exam, Vitals
Measured: Up to 6 months
Time to Progression
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.
Measured: Every 8 weeks, assesed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2012
- Study completionNov 2012
Why it stopped: Study was closed at the suggestion of DSMB prior to obtaining target enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label Phase II trial that will utilize a Simon two stage acquisition of patients with evaluable relapsed and/or refractory melanoma.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward A. Sausville, MD, PhD, Principal investigator, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729807
- Sponsor's protocol ID
- H-29873;HP-00040559
- Other IDs
- CDR0000602047, HP-00047658, CINJ-090803, 0220090161, R21CA135624
- Status last verified
- Jun 2019
- First submitted
- 7 Aug 2008
- Last updated
- 16 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints
- ClinicalTrials.gov ID
- NCT00729807
- Acronym / sponsor ID
- H-29873;HP-00040559
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed at the suggestion of DSMB prior to obtaining target enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2008 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 21 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label Phase II trial that will utilize a Simon two stage acquisition of patients with evaluable relapsed and/or refractory melanoma.
| Arm | Type | Receives |
|---|---|---|
| Pentamidine | Experimental | Drug: pentamidine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentamidine | Drug | Pentamidine |
Primary outcome
Response Rate in Patients Treated With Pentamidine
Time frame: 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)
6 secondary outcomes
Number of Participants With Both p21 and S100B Expression in Accessible Tumor Biopsies Pre Pentamidine Exposure in Cycle 1
Time frame: Pre-Study, an average of 12 days
Number of Participants With p21 and S100B Expression in Accessible Tumor Biopsies Post Pentamidine Exposure
Time frame: Day 12 Cycle 1
Expression of S100B Pre Pentamidine Exposure
Time frame: Pre-Study
Expression of S100B
Time frame: Cycle 1 Day 8, Cycle 1 Day 12, Cycle 2 Day 8, Cycle 2 Day 12
Number of Participants With Serious and Non Serious Adverse Events
Time frame: Up to 6 months
Time to Progression
Time frame: Every 8 weeks, assesed up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward A. Sausville, MD, PhD principal investigator
University of Maryland Greenebaum Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pentamidine in people with Melanoma (Skin), run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate in Patients Treated With Pentamidine (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.