Clinical trial NCT00031564: Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2
Official title: Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2 for Patients With Stage IV Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage IV
renal cell carcinoma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Chiron Corporation
First posted: 2003-01-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.

Detailed description: OBJECTIVES:

* Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2.
* Determine the immunogenicity of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.
* Determine the local and systemic toxicity of this regimen in these patients.

OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis.

At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks after the last dose of IL-2.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV renal cell carcinoma

  * Symptomatic primary tumor or resectable metastasis
* Measurable disease post resection
* No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
* Hematocrit greater than 30%

Hepatic:

* Bilirubin less than 2 times normal
* SGOT less than 3 times normal

Renal:

* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No contraindications to surgical resection
* No history of immunodeficiency disease
* No known allergy to penicillin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior interleukin-2, interferon alfa, or other biologic agent allowed

Chemotherapy:

* Not specified

Endocrine therapy:

* No concurrent corticosteroids (except for replacement doses for adrenal insufficiency)

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* No concurrent immunosuppressants

Primary outcomes:
measure: Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Scott J. Antonia, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fishman M, Hunter TB, Soliman H, Thompson P, Dunn M, Smilee R, Farmelo MJ, Noyes DR, Mahany JJ, Lee JH, Cantor A, Messina J, Seigne J, Pow-Sang J, Janssen W, Antonia SJ. Phase II trial of B7-1 (CD-86) transduced, cultured autologous tumor cell vaccine plus subcutaneous interleukin-2 for treatment of stage IV renal cell carcinoma. J Immunother. 2008 Jan;31(1):72-80. doi: 10.1097/CJI.0b013e31815ba792.