Trial · NCT00729807
0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
NCT00729807, Phase 2, Terminated, University of Maryland, Baltimore; results first posted 2016-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma. Trials, record NCT00729807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00729807
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
- NCT number
- NCT00729807
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Melanoma (Skin)
- Interventions
- pentamidine
- First posted
- 2008-08-08
- Last updated
- 2019-08-16
- Results first posted
- 2016-10-21
- Limitations and caveats
- Unable to reach the target number of participants needed before study was closed at the suggestion of DSMB
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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 |
| Secondary | Expression of S100B Pre Pentamidine Exposure | Pre-Study | Serum for S100B |
| Secondary | Expression of S100B | Cycle 1 Day 8, Cycle 1 Day 12, Cycle 2 Day 8, Cycle 2 Day 12 | Serum for S100B level |
| Secondary | Number of Participants With Serious and Non Serious Adverse Events | Up to 6 months | Metabolic Panel, Physical Exam, Vitals |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Six participants analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Only data for 1 site was analyzed for this outcome measure | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With p21 and S100B Expression in Accessible Tumor Biopsies Post Pentamidine Exposure | Day 12 Cycle 1 | Only 1 participant from 1 site had a biopsy collected and analyzed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Expression of S100B Pre Pentamidine Exposure | Pre-Study | Only data for 1 site was analyzed for this outcome measure. | pg/ml | MEDIAN |
| SECONDARY | Expression of S100B | Cycle 1 Day 8, Cycle 1 Day 12, Cycle 2 Day 8, Cycle 2 Day 12 | Only data from 1 site was analyzed for this outcome measure | pg/ml | MEDIAN |
| SECONDARY | Number of Participants With Serious and Non Serious Adverse Events | Up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Progression | Every 8 weeks, assesed up to 6 months | Only data for 1 site was analyzed for this outcome measure. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate in Patients Treated With Pentamidine | Pentamidine | 0 | Participants | ||
| Number of Participants With Both p21 and S100B Expression in Accessible Tumor Biopsies Pre Pentamidine Exposure in Cycle 1 | Pentamidine | 3 | Participants | ||
| Number of Participants With p21 and S100B Expression in Accessible Tumor Biopsies Post Pentamidine Exposure | Pentamidine | 1 | Participants | ||
| Expression of S100B Pre Pentamidine Exposure | Pentamidine | 332.5 | Full Range 116.5 to 5090 | pg/ml | |
| Expression of S100B | Pentamidine | C1D8 | 450 | Full Range 88.1 to 5679 | pg/ml |
| Expression of S100B | Pentamidine | C1D12 | 137 | Full Range 74 to 5409 | pg/ml |
| Expression of S100B | Pentamidine | C2D8 | 142.1 | Full Range 125 to 159.2 | pg/ml |
| Expression of S100B | Pentamidine | C2D12 | 150 | Full Range 150 to 150 | pg/ml |
| Number of Participants With Serious and Non Serious Adverse Events | Pentamidine | 6 | Participants | ||
| Time to Progression | Pentamidine | 36 | Full Range 36 to 51 | days |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm | 6 | |
| Overall Study | COMPLETED | Treatment Arm | 6 | |
| Overall Study | NOT COMPLETED | Treatment Arm | 0 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anorexia | Gastrointestinal disorders | Treatment Arm | 2 | 6 | 2 |
| other | Anxiety | Psychiatric disorders | Treatment Arm | 2 | 6 | 2 |
| other | Blood in urine | Renal and urinary disorders | Treatment Arm | 2 | 6 | 2 |
| other | Creatinine | Renal and urinary disorders | Treatment Arm | 2 | 6 | 4 |
| other | Deep vein thrombosis | Blood and lymphatic system disorders | Treatment Arm | 1 | 6 | 1 |
| other | Dehydration | Metabolism and nutrition disorders | Treatment Arm | 1 | 6 | 1 |
| other | Dry heaves | Gastrointestinal disorders | Treatment Arm | 1 | 6 | 2 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Treatment Arm | 1 | 6 | 2 |
| other | Edema | Blood and lymphatic system disorders | Treatment Arm | 1 | 6 | 2 |
| other | Erythema | Skin and subcutaneous tissue disorders | Treatment Arm | 1 | 6 | 2 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm | ||
| Total, other adverse events | Treatment Arm | 6 | 6 |
| Total, serious adverse events | Treatment Arm | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21CA135624 | Treatment of Melanoma with wild-type P53 and detectable S100B using pentamidine: | SAUSVILLE, EDWARD A. | UNIVERSITY OF MARYLAND BALTIMORE | NATIONAL CANCER INSTITUTE | 2008 to 2009 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00729807
GET https://conductscience.org/api/trials/v1/NCT00729807/events?page=2