Trial · NCT01100528
Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
NCT01100528, Phase 2, Completed, Case Comprehensive Cancer Center; results first posted 2018-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance. Trials, record NCT01100528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01100528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
- NCT number
- NCT01100528
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Case Comprehensive Cancer Center
- Conditions
- Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Iris Melanoma, Recurrent Intraocular Melanoma
- Interventions
- recombinant interferon alfa-2b, dacarbazine, laboratory biomarker analysis
- First posted
- 2010-04-09
- Last updated
- 2019-02-26
- Results first posted
- 2018-10-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Disease-free Survival (DFS) | 5 years from time-of-enrollment | DFS will be calculated from the date treatment starts to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier. Treatment will be considered relatively ineffective in this population if the underlying 2-year DFS is \<60%, whereas the combination will be considered promising if the underlying rate is \>80%. |
| Secondary | Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0 | up to 32 weeks from start of study | Number of participants with toxicity as defined as an underlying risk of \>33% Grade 3 (non blood/bone marrow) or Grade 4 adverse events that are related to therapy, assessed by NCI CTCAE version 3.0 |
| Secondary | Changes in Plasma Biomarkers and Their Association With DFS | 5 yrs from start of treatment | Plasma levels of these markers will be summarized at baseline and over time quantitatively and graphically. Specific regulators of immune escape and tumor cell invasion identified in uveal melanoma gene array studies will be measured. Peripheral blood cells and plasma will be analyzed for granulysin (a measure of natural killer cells (NK) activity), beta2-microglobulin, autotoxin, lysophosphatidic acid (a product of autotaxin), matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin. |
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 | Number of Patients With Disease-free Survival (DFS) | 5 years from time-of-enrollment | All patients enrolled in study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0 | up to 32 weeks from start of study | All patients enrolled on study regardless of treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Plasma Biomarkers and Their Association With DFS | 5 yrs from start of treatment | Information not collected |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Disease-free Survival (DFS) | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 8 | Participants | ||
| Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0 | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | Participants |
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 | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 38 | |
| Overall Study | COMPLETED | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 35 | |
| Overall Study | NOT COMPLETED | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 3 |
Source ClinicalTrials.gov
Adverse events47
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 | Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Lymphocele | Blood and lymphatic system disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Mood alteration - Anxiety | Nervous system disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Neuropathy: sensory | Nervous system disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Ocular/Visual - vision impaired | Eye disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Ophthalmoplegia/diplopia (double vision) | Eye disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Pain - Back | General disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 3 |
| other | Pain - Extremity-limb | General disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
| other | Pain - Joint | General disorders | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 | 2 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 10 | 38 |
| Total, other adverse events | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 38 | 38 |
| Total, serious adverse events | Arm I: Dacarbazine + Recombinant Interferon Alfa-2b | 2 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31371315 | 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/NCT01100528
GET https://conductscience.org/api/trials/v1/NCT01100528/events?page=2