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Kidney CancerPhase 2NCT00002589

Lymphocyte Therapy in Treating Patients With Kidney Cancer

A Phase 2 study testing aldesleukin, muromonab-CD3 and therapeutic autologous lymphocytes in people with Kidney Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
aldesleukin, muromonab-CD3 and therapeutic autologous lymphocytes
Type of treatment
Surgery or procedure
How many people
90 participants
Where
1 siteUnited States
Study dates
Jul 1994to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Milwaukee, Wisconsin, 53201-2901

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
aldesleukin, muromonab-CD3, therapeutic autologous lymphocytes, adjuvant therapy
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival as measured by Kaplan-Meier method at 5 years

  2. Onset of recurrence as measured by Kaplan-Meier method at 5 years

  3. Safety as measured by NCI Common Toxicity Criteria at completion of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 1994

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002589
Sponsor's protocol ID
CDR0000063744
Other IDs
STLMC-BRM-9401, NCI-V94-0514
Status last verified
Dec 2005
First submitted
1 Nov 1999
Last updated
18 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aldesleukin, muromonab-CD3 and therapeutic autologous lymphocytes in people with Kidney Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival as measured by Kaplan-Meier method at 5 years. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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