Trial Outcomes & Findings for RFT-5-dgA in Patients With Metastatic Melanoma (NCT NCT00314093)
NCT ID: NCT00314093
Last Updated: 2019-11-12
Results Overview
The primary objective is to determine whether objective clinical responses can be obtained in patients with metastatic melanoma following administration of RFT5-dgA
COMPLETED
PHASE2
41 participants
up to one year
2019-11-12
Participant Flow
Enrollment reflects the anticipated enrollment. Actual enrollment is unknown due to no longer having access to the data as records were destroyed.
Participant milestones
| Measure |
No Study Data Available
Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed. No study data are available
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|---|---|
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RFT-5-dgA in Patients With Metastatic Melanoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: up to one yearPopulation: Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
The primary objective is to determine whether objective clinical responses can be obtained in patients with metastatic melanoma following administration of RFT5-dgA
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before to after treatmentPopulation: Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
Secondary objectives will determine whether changes occur in levels of CD4+CD25+ regulatory T cells (Treg cells) in peripheral blood from before to after treatment and evaluate the toxicity profile of patients treated on this trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
Secondary objectives will determine whether changes occur in levels of CD4+CD25+ regulatory T cells (Treg cells) in peripheral blood from before to after treatment and evaluate the toxicity profile of patients treated on this trial.
Outcome measures
Outcome data not reported
Adverse Events
Data Not Able to be Obtained
Serious adverse events
| Measure |
Data Not Able to be Obtained
Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
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|---|---|
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Investigations
No Data Available
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—
0/0
Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
|
Other adverse events
| Measure |
Data Not Able to be Obtained
Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
|
|---|---|
|
Investigations
No Data Available
|
—
0/0
Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed
|
Additional Information
Dr. Ellen Vitetta
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place