Trial · NCT00925132
Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat
NCT00925132, Phase 1, Phase 2, Terminated, University of Iowa; results first posted 2017-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat. Trials, record NCT00925132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00925132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat
- NCT number
- NCT00925132
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- University of Iowa
- Conditions
- Metastatic Melanoma
- Interventions
- Temozolomide, Decitabine, Panobinostat
- First posted
- 2009-06-19
- Last updated
- 2017-07-02
- Results first posted
- 2017-07-02
- Limitations and caveats
This study was closed to enrollment early as there was a change in the number of approved drugs for metastatic melanoma, making Temozolomide as a chemotherapy agent, an unlikely treatment for metastatic melanoma.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level | 6 weeks (one full cycle) | A DLT was any Grade 4 toxicity for neutrophils or platelets for ≥ 7 days, Grade 3 toxicity for neutrophils for ≥ 21 days, any Grade 3 solid organ toxicity not explainable by another cause (e.g. neurotoxicity, GI toxicity), metabolic/laboratory toxicity (≥10 x ULN AST) for ≥ 14 days, any Grade 4 infection or QTcF\> 500msec EKG. DLTs were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. All adverse events were collected and graded to determine DLTs as assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. DLTs were assessed to determine the recommended Decitabine and Panobinostat dose for the Phase II portion of the trial. |
| Primary | Phase 2 -Number of Patients With a Decrease in Tumor Size Using RECIST and CHOI's Criteria | 12 weeks (2 cycles) | Tumor response rate was assessed using RECIST criteria in which a complete response was the disappearance of all target lesions; Partial response was a 30% decrease in the sum of the longest dimension (LD) of target lesions, relative to baseline measurement; Progressive disease was an increase of 20% or more in the sum of the LD of target lesions; and Stable disease was a decrease in tumor size of less than 30% or increase of less than 20%. Tumor response rate was also assessed using CHOI's criteria in which a response was a 10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced computed tomography scan. Tumor response rates were assessed in order to determine effectiveness of the treatment regimen which was defined by the response rate of at least 30% as measured by either the RECIST or Choi's criteria, and ineffective if the rate is less than 15% on both. |
| Secondary | Phase 2 - Number of Participants With Disease Progression | 5 years | Number of participants who died or had disease progression |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level | 6 weeks (one full cycle) | Number of patients within the 4 dosing cohorts evaluable for DLTs following administration of one full cycle | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2 -Number of Patients With a Decrease in Tumor Size Using RECIST and CHOI's Criteria | 12 weeks (2 cycles) | Number of patients evaluable for tumor response assessment following 2 cycles of treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2 - Number of Participants With Disease Progression | 5 years | Number patients who received study drug in Phase II portion of trial | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level | Phase I Dose Escalation | Cohort 1: Experienced DLT | 0 | Participants | |
| Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level | Phase I Dose Escalation | Cohort 2: Experienced DLT | 0 | Participants | |
| Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level | Phase I Dose Escalation | Cohort 3: Experienced DLT | 0 | Participants | |
| Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level | Phase I Dose Escalation | Cohort 4: Experienced DLT | 0 | Participants | |
| Phase 2 -Number of Patients With a Decrease in Tumor Size Using RECIST and CHOI's Criteria | Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg +Temozolomide | Progressive Disease (PD) | 12 | Participants | |
| Phase 2 -Number of Patients With a Decrease in Tumor Size Using RECIST and CHOI's Criteria | Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg +Temozolomide | Stable Disease (SD) | 5 | Participants | |
| Phase 2 - Number of Participants With Disease Progression | Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg+Temozolomide | Died within 5 year time frame | 17 | Participants | |
| Phase 2 - Number of Participants With Disease Progression | Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg+Temozolomide | Removed due to disease progression | 5 | Participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I:Decitabine 0.1mg/kg + Panobinostat 10mg + Temozolomide | 5 | |
| Overall Study | STARTED | Phase I:Decitabine 0.1 mg/kg + Panobinostat 20mg +Temozolomide | 4 | |
| Overall Study | STARTED | Phase I:Decitabine 0.2 mg/kg + Panobinostat 20mg+Temozolomide | 4 | |
| Overall Study | STARTED | Phase I:Decitabine 0.2 mg/kg + Panobinostat 30mg +Temozolomide | 4 | |
| Overall Study | STARTED | Phase II:Decitabine 0.2 mg/kg+Panobinostat 30mg+Temozolomide | 22 | |
| Overall Study | COMPLETED | Phase I:Decitabine 0.1mg/kg + Panobinostat 10mg + Temozolomide | 3 | |
| Overall Study | COMPLETED | Phase I:Decitabine 0.1 mg/kg + Panobinostat 20mg +Temozolomide | 4 | |
| Overall Study | COMPLETED | Phase I:Decitabine 0.2 mg/kg + Panobinostat 20mg+Temozolomide | 4 | |
| Overall Study | COMPLETED | Phase I:Decitabine 0.2 mg/kg + Panobinostat 30mg +Temozolomide | 4 | |
| Overall Study | COMPLETED | Phase II:Decitabine 0.2 mg/kg+Panobinostat 30mg+Temozolomide | 17 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events54
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 | Leukocytes | Blood and lymphatic system disorders | Temozolomide, Decitabine, Panobinostat | 24 | 39 | 24 |
| other | Lymphopenia | Blood and lymphatic system disorders | Temozolomide, Decitabine, Panobinostat | 29 | 39 | 29 |
| other | RBC Decreased | Blood and lymphatic system disorders | Temozolomide, Decitabine, Panobinostat | 2 | 39 | 2 |
| other | Hemoglobin | Blood and lymphatic system disorders | Temozolomide, Decitabine, Panobinostat | 14 | 39 | 14 |
| other | Neutrophils | Blood and lymphatic system disorders | Temozolomide, Decitabine, Panobinostat | 27 | 39 | 27 |
| other | Platelets | Blood and lymphatic system disorders | Temozolomide, Decitabine, Panobinostat | 24 | 39 | 24 |
| other | Fatigue | General disorders | Temozolomide, Decitabine, Panobinostat | 24 | 39 | 24 |
| other | Fever | General disorders | Temozolomide, Decitabine, Panobinostat | 3 | 39 | 3 |
| other | Anorexia | Gastrointestinal disorders | Temozolomide, Decitabine, Panobinostat | 13 | 39 | 13 |
| other | Constipation | Gastrointestinal disorders | Temozolomide, Decitabine, Panobinostat | 9 | 39 | 9 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide, Decitabine, Panobinostat | ||
| Total, other adverse events | Temozolomide, Decitabine, Panobinostat | 39 | 39 |
| Total, serious adverse events | Temozolomide, Decitabine, Panobinostat | 5 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25062770 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT00925132
GET https://conductscience.org/api/trials/v1/NCT00925132/events?page=2