Who is sponsoring NCT00101166?

NCT00101166 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What condition does NCT00101166 study?

NCT00101166 studies Melanoma (Skin).

What drugs are being tested in NCT00101166?

Interventions: Bystander-Based Autologous Tumor Cell Vaccine.

What is the status of NCT00101166?

NCT00101166 is currently COMPLETED.

Last reviewed 2018-01-31 · How we verify

A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma

NCT00101166 Phase 2 COMPLETED Results posted

The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.

Details

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 2
Status	COMPLETED
Enrolment	43
Start date	2004-10
Completion	2010-03

Conditions

Melanoma (Skin)

Interventions

Bystander-Based Autologous Tumor Cell Vaccine

Primary outcomes

Number of Participants With Partial Response — Average of 14 months
Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Countries

United States