Lymphocyte Therapy in Treating Patients With Kidney Cancer
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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 |
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| United States, Wisconsin | |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53201-2901 | |
| Study Chair: | John P. Hanson, MD | St. Luke's Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002589 History of Changes |
| Other Study ID Numbers: | CDR0000063744, STLMC-BRM-9401, NCI-V94-0514 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Adjuvants, Immunologic |
Muromonab-CD3 Aldesleukin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antineoplastic Agents Therapeutic Uses Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013