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


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Survival as measured by Kaplan-Meier method at 5 years

Safety Issue:

No

Principal Investigator

John P. Hanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Luke's Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000063744

NCT ID:

NCT00002589

Start Date:

July 1994

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901