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Lymphocyte Therapy in Treating Patients With Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
muromonab-CD3
therapeutic autologous lymphocytes
adjuvant therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 17, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002589
Brief Title
Lymphocyte Therapy in Treating Patients With Kidney Cancer
Official Title
Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
muromonab-CD3
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Survival as measured by Kaplan-Meier method at 5 years
Title
Onset of recurrence as measured by Kaplan-Meier method at 5 years
Title
Safety as measured by NCI Common Toxicity Criteria at completion of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Hanson, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201-2901
Country
United States

12. IPD Sharing Statement

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Lymphocyte Therapy in Treating Patients With Kidney Cancer

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