Lymphocyte Therapy in Treating Patients With Kidney Cancer

December 17, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201-2901
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival as measured by Kaplan-Meier method at 5 years
Onset of recurrence as measured by Kaplan-Meier method at 5 years
Safety as measured by NCI Common Toxicity Criteria at completion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: John P. Hanson, MD, St. Luke's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1994

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000063744
  • STLMC-BRM-9401
  • NCI-V94-0514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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