Lymphocyte Therapy in Treating Patients With Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002589
• Other study ID #: CDR0000063744
• Secondary ID: STLMC-BRM-9401NC
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 17, 2013
• Start date: July 1994

Study information

• Verified date: December 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

• muromonab-CD3

• therapeutic autologous lymphocytes

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival as measured by Kaplan-Meier method at 5 years			No
Primary	Onset of recurrence as measured by Kaplan-Meier method at 5 years			No
Primary	Safety as measured by NCI Common Toxicity Criteria at completion of study			Yes