Mix Vaccine for Metastatic Kidney Cancer

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Reaction - Mixed Vaccine; Metastasis From Malignant Tumor of Kidney (Disorder)

Treatments: Biological: Mix vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03357289

kidney cancer MV

Details and patient eligibility

About

The aim of this study is the safety and efficacy of mix vaccine to small metastases of kidney cancer.

Full description

By enrolling patients with small metastases of kidney cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Enrollment: 30 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
• Body tumor 1-6, the maximum tumor length < 2 cm
• KPS ≥ 70, lifespan > 6 months
• Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion criteria

• Patients with cardiac pacemaker
• Patients with brain metastasis
• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Mix vaccine

Experimental group

Description:

In this group, the patients will receive mix vaccine. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Treatment:

Biological: Mix vaccine

Control

No Intervention group

Description:

In this group, the patients will receive no special treatment and as a control group. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).