Trial · NCT00482911

Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma

NCT00482911, Phase 2, Terminated, National Institutes of Health Clinical Center (CC); results first posted 2012-11-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma. Trials, record NCT00482911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00482911

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma
NCT number: NCT00482911
Status: Terminated
Phases: Phase 2
Enrollment: 12 participants, actual
Lead sponsor: National Institutes of Health Clinical Center (CC)
Conditions: Intraocular Melanoma, Malignant Conjunctival Neoplasm
Interventions: cyclophosphamide, lenalidomide, sunitinib malate
First posted: 2007-06-05
Last updated: 2017-03-27
Results first posted: 2012-11-14

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Rate (Complete and Partial Response)	2 years	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Primary	Toxicity	16 months	Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Primary	Overall Survival	up to 16 months	Time from date of on study to the date of death from any cause or last follow up
Secondary	Progression Free Survival	up to 16 months	Proportion of patients who progress or die after the start of treatment
Secondary	Changes in Gene Expression, Methylation and Protein Modification	Baseline and end of treatment course 1 and 2, approximately 42 days	Ribonucleic acid (RNA), deoxyribonucleic acid (DNA) and protein obtained from blood, urine and/or tissue was to be evaluated for changes in gene expression, methylation and/or protein modification.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rate (Complete and Partial Response)	2 years	Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.	Participants	NUMBER
PRIMARY	Toxicity	16 months	Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.	Participants	NUMBER
PRIMARY	Overall Survival	up to 16 months	Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished.
SECONDARY	Progression Free Survival	up to 16 months	Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished
SECONDARY	Changes in Gene Expression, Methylation and Protein Modification	Baseline and end of treatment course 1 and 2, approximately 42 days	Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished

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	Units
Response Rate (Complete and Partial Response)	Cohort 1-lenalidomide & Cyclophosphamide	Complete Response	0	Participants
Response Rate (Complete and Partial Response)	Cohort 2-sunitinib & Cyclophosphamide	Complete Response	0	Participants
Response Rate (Complete and Partial Response)	Cohort 1-lenalidomide & Cyclophosphamide	Partial Response	0	Participants
Response Rate (Complete and Partial Response)	Cohort 2-sunitinib & Cyclophosphamide	Partial Response	0	Participants
Toxicity	Cohort 1-lenalidomide & Cyclophosphamide		3	Participants
Toxicity	Cohort 2-sunitinib & Cyclophosphamide		8	Participants

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Dosing Schedule 1: Len & Cyc	STARTED	Cohort 1-lenalidomide & Cyclophosphamide	3
Dosing Schedule 1: Len & Cyc	STARTED	Cohort 2-sunitinib & Cyclophosphamide	0
Dosing Schedule 1: Len & Cyc	COMPLETED	Cohort 1-lenalidomide & Cyclophosphamide	3
Dosing Schedule 1: Len & Cyc	COMPLETED	Cohort 2-sunitinib & Cyclophosphamide	0
Dosing Schedule 1: Len & Cyc	NOT COMPLETED	Cohort 1-lenalidomide & Cyclophosphamide	0
Dosing Schedule 1: Len & Cyc	NOT COMPLETED	Cohort 2-sunitinib & Cyclophosphamide	0
Dosing Schedule 1: Len, Cyc, & Sun	STARTED	Cohort 1-lenalidomide & Cyclophosphamide	3
Dosing Schedule 1: Len, Cyc, & Sun	STARTED	Cohort 2-sunitinib & Cyclophosphamide	2
Dosing Schedule 1: Len, Cyc, & Sun	COMPLETED	Cohort 1-lenalidomide & Cyclophosphamide	3
Dosing Schedule 1: Len, Cyc, & Sun	COMPLETED	Cohort 2-sunitinib & Cyclophosphamide	2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events96

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	Albumin, serum-low (hypoalbuminemia)	Metabolism and nutrition disorders	Cohort 1-lenalidomide & Cyclophosphamide	1	3	1
other	Albumin, serum-low (hypoalbuminemia)	Metabolism and nutrition disorders	Cohort 2-sunitinib & Cyclophosphamide	1	9	1
other	Constipation	Gastrointestinal disorders	Cohort 1-lenalidomide & Cyclophosphamide	2	3	2
other	Constipation	Gastrointestinal disorders	Cohort 2-sunitinib & Cyclophosphamide	4	9	11
other	Diarrhea	Gastrointestinal disorders	Cohort 1-lenalidomide & Cyclophosphamide	2	3	2
other	Diarrhea	Gastrointestinal disorders	Cohort 2-sunitinib & Cyclophosphamide	4	9	7
other	Distension/bloating, abdominal	Gastrointestinal disorders	Cohort 1-lenalidomide & Cyclophosphamide	1	3	1
other	Distension/bloating, abdominal	Gastrointestinal disorders	Cohort 2-sunitinib & Cyclophosphamide	1	9	1
other	Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	Cohort 1-lenalidomide & Cyclophosphamide	1	3	1
other	Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	Cohort 2-sunitinib & Cyclophosphamide	1	9	1

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1-lenalidomide & Cyclophosphamide
Total, all-cause mortality	Cohort 2-sunitinib & Cyclophosphamide
Total, other adverse events	Cohort 1-lenalidomide & Cyclophosphamide	3	3
Total, other adverse events	Cohort 2-sunitinib & Cyclophosphamide	8	9
Total, serious adverse events	Cohort 1-lenalidomide & Cyclophosphamide	0	3
Total, serious adverse events	Cohort 2-sunitinib & Cyclophosphamide	2	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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-lenalidomide & Cyclophosphamide vs Cohort 2-sunitinib & Cyclophosphamide: Toxicity	Trial comparisons
Cohort 1-lenalidomide & Cyclophosphamide vs Cohort 2-sunitinib & Cyclophosphamide: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00482911

GET https://conductscience.org/api/trials/v1/NCT00482911/events?page=2

API reference For AI assistants