Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma

This study has been terminated.

(study was stopped due to low accrual)

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00924001

First received: June 17, 2009

Last updated: October 18, 2012

Last verified: October 2012

History of Changes

Results First Received: December 22, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Melanoma Malignant Melanoma Melanoma, Experimental
Interventions:	Drug: DMF5 Melanoma Reactive TIL Drug: Cyclophosphamide Drug: Fludarabine Drug: Aldesleukin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One participant was enrolled to this study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Metastatic Melanoma	Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.

Participant Flow: Overall Study

	Metastatic Melanoma
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Metastatic Melanoma	Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.

Baseline Measures

	Metastatic Melanoma
Number of Participants [units: participants]	1
Age [units: participants]
<=18 years	0
Between 18 and 65 years	1
>=65 years	0
Age [units: years] Mean ± Standard Deviation	32.0
Gender [units: participants]
Female	0
Male	1
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0
Not Hispanic or Latino	1
Unknown or Not Reported	0
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	1
More than one race	0
Unknown or Not Reported	0
Region of Enrollment [units: participants]
United States	1

Outcome Measures

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1. Primary:

Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria [ Time Frame: 44 days ]

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2. Primary:

Number of Participants With Adverse Events [ Time Frame: 44 days ]

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3. Secondary:

Number of Participiants With In-vivo Survival of Infused Cells [ Time Frame: 44 days ]

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Measure Type	Secondary
Measure Title	Number of Participiants With In-vivo Survival of Infused Cells
Measure Description	In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).
Time Frame	44 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Metastatic Melanoma	Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.

Measured Values

	Metastatic Melanoma
Number of Participants Analyzed [units: participants]	1
Number of Participiants With In-vivo Survival of Infused Cells [units: Participants]	1

No statistical analysis provided for Number of Participiants With In-vivo Survival of Infused Cells

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4164
e-mail: sar@mail.nih.gov

Publications:

Mills CD, North RJ. Expression of passively transferred immunity against an established tumor depends on generation of cytolytic T cells in recipient. Inhibition by suppressor T cells. J Exp Med. 1983 May 1;157(5):1448-60.

Fernandez-Cruz E, Woda BA, Feldman JD. Elimination of syngeneic sarcomas in rats by a subset of T lymphocytes. J Exp Med. 1980 Oct 1;152(4):823-41.

Greenberg PD, Kern DE, Cheever MA. Therapy of disseminated murine leukemia with cyclophosphamide and immune Lyt-1+,2- T cells. Tumor eradication does not require participation of cytotoxic T cells. J Exp Med. 1985 May 1;161(5):1122-34.

Responsible Party:	Steven A. Rosenberg, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00924001 History of Changes
Obsolete Identifiers:	NCT00537069
Other Study ID Numbers:	070210, 07-C-0210
Study First Received:	June 17, 2009
Results First Received:	December 22, 2011
Last Updated:	October 18, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

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