Trial · NCT00109005
Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma
NCT00109005, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma. Trials, record NCT00109005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00109005
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma
- NCT number
- NCT00109005
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Melanoma
- Interventions
- Revlimid
- First posted
- 2005-04-22
- Last updated
- 2017-01-02
- Results first posted
- 2012-10-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Responses in Patients With Metastatic Ocular Melanoma | 12 months | Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Primary | Number of Participants With Adverse Events | 24 months | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
| Secondary | Progression Free Survival | up to 2 years | Time interval from start of treatment to documented evidence of disease progression. |
| Secondary | Overall Survival | up to 2 years | Date of on-study to the date of death from any cause or last follow up. |
| Secondary | Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg | Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours. | Plasma samples will be obtained and plasma concentrations will be determined by a reversed-phase high-performance liquid chromatography (HPLC) assay using mass spectrometry (MS) detection. |
| Secondary | Determine Dose Level With Superior Efficacy and Acceptable Toxicity | up to 2 years | The most efficacious dose (with greater number of responses) with acceptable toxicity profile will be considered for use in subsequent trials. iI the number of responses is tied, then toxicity criteria (Common Terminology criteria (CTC) v3.0) will be used to select the preferred dose. |
| Secondary | Evaluate Effects of Lenalidomide on Pathways | Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy. | Tissue will be obtained to evaluate the effects of lenalidomide on pathways thought to be modulated by lenalidomide. |
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 | Clinical Responses in Patients With Metastatic Ocular Melanoma | 12 months | Response data was combined for this outcome measure. Results are available for the combined cohorts only.~Sixteen out of seventeen patients were eligible for response assessments. | Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events | 24 months | Participants | NUMBER | |
| SECONDARY | Progression Free Survival | up to 2 years | This outcome measure was not analyzed because the investigator left the institution. | ||
| SECONDARY | Overall Survival | up to 2 years | This outcome measure was not analyzed because the investigator left the institution. | ||
| SECONDARY | Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg | Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours. | This outcome measure was not analyzed because the investigator left the institution. | ||
| SECONDARY | Determine Dose Level With Superior Efficacy and Acceptable Toxicity | up to 2 years | This outcome measure was not analyzed because the investigator left the institution. | ||
| SECONDARY | Evaluate Effects of Lenalidomide on Pathways | Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy. | This outcome measure was not analyzed because the investigator left the institution. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Responses in Patients With Metastatic Ocular Melanoma | Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid) | Complete Response | 0 | Participants | |
| Clinical Responses in Patients With Metastatic Ocular Melanoma | Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid) | Partial Response | 0 | Participants | |
| Clinical Responses in Patients With Metastatic Ocular Melanoma | Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid) | Progressive Disease | 9 | Participants | |
| Clinical Responses in Patients With Metastatic Ocular Melanoma | Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid) | Stable Disease | 7 | Participants | |
| Number of Participants With Adverse Events | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 8 | Participants | ||
| Number of Participants With Adverse Events | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 9 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 8 | |
| Overall Study | STARTED | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 9 | |
| Overall Study | COMPLETED | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 8 | |
| Overall Study | COMPLETED | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 9 | |
| Overall Study | NOT COMPLETED | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 0 |
Source ClinicalTrials.gov
Adverse events84
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 1 | 8 | 2 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 1 | 9 | 1 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 2 | 8 | 2 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 2 | 9 | 3 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 1 | 8 | 1 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 0 | 9 | 0 |
| other | Alkaline phosphatase | Investigations | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 1 | 8 | 3 |
| other | Alkaline phosphatase | Investigations | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 3 | 9 | 3 |
| other | Constipation | Gastrointestinal disorders | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 1 | 8 | 1 |
| other | Constipation | Gastrointestinal disorders | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 0 | 9 | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - 25 mg Lenalidomide (Revlimid) | ||
| Total, all-cause mortality | Cohort 2 - 5 mg Lenalidomide (Revlimid) | ||
| Total, other adverse events | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 8 | 8 |
| Total, other adverse events | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 9 | 9 |
| Total, serious adverse events | Cohort 1 - 25 mg Lenalidomide (Revlimid) | 1 | 8 |
| Total, serious adverse events | Cohort 2 - 5 mg Lenalidomide (Revlimid) | 1 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 2023760 | BACKGROUND |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 - 25 mg Lenalidomide (Revlimid) vs Cohort 2 - 5 mg Lenalidomide (Revlimid): Number of Participants With Adverse Events | Trial comparisons |
| Cohort 1 - 25 mg Lenalidomide (Revlimid) vs Cohort 2 - 5 mg Lenalidomide (Revlimid): serious adverse events | Trial comparisons |
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/NCT00109005
GET https://conductscience.org/api/trials/v1/NCT00109005/events?page=2