Lymphocyte Therapy in Treating Patients With Kidney Cancer

NCT ID: NCT00002589

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-07-31

Brief Summary

RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may help them kill more cancer cells when they are put back in the body.

PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV kidney cancer.

Detailed Description

OBJECTIVES:

• Evaluate the ability of autologous lymphocyte therapy (ALT) given as adjuvant therapy following nephrectomy and/or complete surgical resection of any metastatic disease to delay or prevent metastatic recurrence in patients with high-risk renal cell carcinoma.
• Determine the incidence of tumor recurrence and the survival of these patients treated with this regimen.
• Determine the toxicity/morbidity of this regimen in these patients.
• Explore the relationship between clinical response and in vitro autologous lymphocyte characteristics, including lytic activity, cytokine production, response to cytokines, and phenotypic profile in these patients treated with this regimen.
• Assess patient immune status before, during, and after therapy.

OUTLINE: Patients are stratified according to postnephrectomy interval (less than 3 months vs more than 3 months), extent of lymph node involvement (N1 vs N2-N3), interleukin-1 concentration in initial autologous lymphocyte culture (less than 500 pg/mL vs greater than 500 pg/mL), and prenephrectomy treatment.

Mononuclear cells are collected by apheresis on day 1 and cultured with interleukin-2 and monoclonal antibody OKT3. After cellular production, the autologous lymphocytes are reinfused over at least 30 minutes. Treatment repeats monthly for 6 months and then every 3 months for 6 months in the absence of unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 10-90 patients will accrued for this study within 3 years.

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

muromonab-CD3

Intervention Type: BIOLOGICAL

therapeutic autologous lymphocytes

Intervention Type: BIOLOGICAL

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically documented and completely resected stage III or stage IV renal cell carcinoma, clinically staged within 2 months prior to initiation of therapy
• No evidence of nephrotic syndrome

PATIENT CHARACTERISTICS:

Age:

• Over 16

Performance status:

• ECOG 0-2

Hematopoietic:

• WBC at least 3,000/mm^3
• Granulocyte count at least 1,500/mm^3
• Platelet count 50,000/mm3 to 500,000/mm^3
• Hemoglobin at least 10 g/dL
• No hematologic abnormalities

Hepatic:

• PT no greater than 1.5 times control
• PTT less than 1.5 times control
• Hepatitis B surface antigen negative

Renal:

• Creatinine no greater than 4.0 mg/dL
• Calcium no greater than 12 mg/dL
• No symptomatic hypercalcemia

Cardiovascular:

• No uncontrolled or severe cardiac disease, e.g.:

• No myocardial infarction within 6 months
• No congestive heart failure

Other:

• HIV negative
• No significant organ dysfunction
• No other serious medical illness that would limit life expectancy
• No significant CNS disease including uncontrolled or untreated psychiatric or seizure disorders
• No uncontrolled bacterial, viral, or fungal infection
• No active peptic or duodenal ulcer
• Adequate peripheral venous access required
• No prior malignancy within past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix
• Not pregnant
• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

• No other concurrent postnephrectomy adjuvant therapy

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No concurrent chemotherapy

Endocrine therapy:

• More than 1 week since prior corticosteroids (except as inhalation therapy for respiratory ailments or replacement for adrenal insufficiency)
• No concurrent therapy with the following:

• Estrogens (except as postmenopausal replacement therapy)
• Androgens
• Progestins
• Antiestrogens
• Antiandrogens
• LHRH analogues or antagonists
• Other hormones

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• No prior solid organ allograft
• More than 3 weeks since major surgery, including nephrectomy

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

John P. Hanson, MD

Role: STUDY_CHAIR

St. Luke's Medical Center

Locations

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

STLMC-BRM-9401

Identifier Type: -

Identifier Source: secondary_id

NCI-V94-0514

Identifier Type: -

Identifier Source: secondary_id

CDR0000063744

Identifier Type: -

Identifier Source: org_study_id