Vaccine Therapy in Treating Patients With Kidney Cancer

Launched by LISATA THERAPEUTICS, INC. · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the safety of immunization with in vitro-treated autologous tumor cells and dendritic cells with sargramostim (GM-CSF) in patients with stage III or IV or recurrent renal cell cancer.
* Determine the frequency of conversion of delayed tumor hypersensitivity tests in these patients treated with this regimen.
* Determine the progression-free and overall survival of these patients treated with this regimen.
* Determine the objective tumor response rate in patients who still have measurable disease at the time they are treated with this regimen.

OUTLINE: Patients are s...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed renal cell carcinoma
• • Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR
• • Recurrent disease involving lymph node metastases or soft tissue nodules
• • Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery)
• • Planned resection of tumor to establish an autologous tumor cell line
• • No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease
• • Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids
• PATIENT CHARACTERISTICS:
• Age:
• • 16 and over
• Performance status:
• • ECOG 0-2
• Life expectancy:
• • At least 4 months
• Hematopoietic:
• • Hematocrit greater than 25%
• • Platelet count greater than 100,000/mm3
• • No ongoing transfusion requirements
• • No active blood clotting or bleeding diathesis
• Hepatic:
• • Bilirubin no greater than 2.0 mg/dL
• • Albumin at least 3.0 g/dL
• • No significant hepatic dysfunction
• Renal:
• • Creatinine no greater than 2.0 mg/dL
• • No significant renal dysfunction
• Cardiovascular:
• • No underlying cardiac disease associated with New York Heart Association class III or IV heart function
• • No unstable angina related to atherosclerotic cardiovascular disease
• Other:
• • No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer
• • No active infection
• • No other active medical condition that could be eminently life threatening
• • Not pregnant
• • Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • Other prior putative vaccines allowed
• • Recovered from prior biologic therapy
• • No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36%
• Chemotherapy:
• • At least 3 weeks since prior chemotherapy and recovered
• • No concurrent chemotherapy
• Endocrine therapy:
• • See Disease Characteristics
• • No concurrent corticosteroids
• Radiotherapy:
• • At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered
• • No concurrent radiotherapy
• Surgery:
• • See Disease Characteristics
• • Recovered from prior surgery
• Other:
• • Concurrent bisphosphonates allowed for patients with lytic bone metastases
• • No concurrent digoxin or other medications designed to improve cardiac output
• • No other concurrent anticancer therapy or investigational therapy