Trial Outcomes & Findings for DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC (NCT NCT00085436)

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

monthly, then every 2-3 months

Results posted on

2018-06-26

Participant Flow

Eligible patients were 18 and older, had measurable disease and newly progressive metastatic or new metastatic disease, tumor tissue for vaccine preparation, and signed consent. Eighteen mRCC patients were enrolled between January 2004 and August 2006.

Participant milestones

Participant milestones
Measure	All Patients Treated With DC Vaccine All patients treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=18 Participants All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	60.8 years STANDARD_DEVIATION 9.83126 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: monthly, then every 2-3 months

Population: Clinical response as measured by RECIST monthly and then every 2-3 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment n=18 Clinical Response All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
Clinical Response as Measured by RECIST	50 percentage of participants Interval 22.0 to 66.0

SECONDARY outcome

Timeframe: monthly for 5 months

All patients receiving at least one week of treatment and have at least two time points available for assessment of immune parameters will be include in the evaluation of immune status.

Outcome measures

Outcome measures
Measure	Treatment n=18 Participants All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
Immunity as Measured by T-cell and Antibody Responses to the Tumor IP-10 Pre treatment	126 pg/mL (picogram/milliliter) Interval 55.0 to 197.0
Immunity as Measured by T-cell and Antibody Responses to the Tumor IP-10 Post treatment	521 pg/mL (picogram/milliliter) Interval 277.0 to 765.0

Adverse Events

Treatment

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=18 participants at risk All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
Skin and subcutaneous tissue disorders Pruritis	27.8% 5/18 • 2 years, 7 months no difference
Skin and subcutaneous tissue disorders Rash	16.7% 3/18 • 2 years, 7 months no difference
Cardiac disorders Hypotension	27.8% 5/18 • 2 years, 7 months no difference
Metabolism and nutrition disorders Metabolic Changes	27.8% 5/18 • 2 years, 7 months no difference
Respiratory, thoracic and mediastinal disorders Hypoxia	11.1% 2/18 • 2 years, 7 months no difference

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marc S. Ernstoff

Dartmouth-Hitchcock Medical Center

Phone: 603-650-5534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place