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Lymphocyte Therapy in Treating Patients With Kidney Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002589
First Posted: January 27, 2003
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Kidney Cancer Biological: aldesleukin Biological: muromonab-CD3 Biological: therapeutic autologous lymphocytes Procedure: adjuvant therapy Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 90
Study Start Date: July 1994
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002589


Locations
United States, Wisconsin
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53201-2901
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: John P. Hanson, MD St. Luke's Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00002589     History of Changes
Other Study ID Numbers: CDR0000063744
STLMC-BRM-9401
NCI-V94-0514
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: December 18, 2013
Last Verified: December 2005

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Aldesleukin
Muromonab-CD3
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents