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Lymphocyte Therapy in Treating Patients With Kidney Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002589
  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
Drug: aldesleukin
Drug: muromonab-CD3
Drug: therapeutic autologous lymphocytes
Procedure: adjuvant therapy
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Aldesleukin Muromonab CD3
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma

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

Primary Outcome Measures:
  • Survival as measured by Kaplan-Meier method at 5 years [ Designated as safety issue: No ]
  • Onset of recurrence as measured by Kaplan-Meier method at 5 years [ Designated as safety issue: No ]
  • Safety as measured by NCI Common Toxicity Criteria at completion of study [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Investigators
Study Chair: John P. Hanson, MD Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000063744, STLMC-BRM-9401, NCI-V94-0514
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002589  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Muromonab-CD3
Carcinoma
Aldesleukin
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009