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High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
Sponsored by
Blumenthal Cancer Center at Carolinas Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma Metastatic disease No pure papillary or sarcomatoid variants Measurable disease Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2 Documented disease progression No estimated hepatic replacement by tumor > 25% by CT scan or MRI No tumor involving the CNS or a major nerve PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Life expectancy More than 3 months Hematopoietic Platelet count ≥ 80,000/mm^3 No sites of ongoing bleeding Hepatic See Disease Characteristics Bilirubin ≤ 1.4 mg/dL AST and ALT ≤ 3 times normal PT or PTT INR ≤ 1.2 Hepatitis B surface antigen negative Hepatitis C virus negative No coagulation disorders Renal Creatinine ≤ 1.6 mg/dL Cardiovascular No ongoing ischemia* No cardiac dysfunction* No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram Pulmonary FEV_1 ≤ 65% of predicted* Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph Other HIV negative No AIDS No systemic infections No other malignancy except carcinoma in situ No psychiatric illness that would preclude study participation or compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy No concurrent steroids Radiotherapy Not specified Surgery Not specified Other More than 28 days since other prior treatment for renal cell cancer No concurrent immunosuppressive agents

Sites / Locations

  • Blumenthal Cancer Center at Carolinas Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
December 18, 2013
Sponsor
Blumenthal Cancer Center at Carolinas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00080977
Brief Title
High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
Official Title
Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Blumenthal Cancer Center at Carolinas Medical Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells. PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.
Detailed Description
OBJECTIVES: Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2. Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug. Determine the toxicity of this drug in these patients. OUTLINE: This is a pilot study. Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1). Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity. Patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma Metastatic disease No pure papillary or sarcomatoid variants Measurable disease Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2 Documented disease progression No estimated hepatic replacement by tumor > 25% by CT scan or MRI No tumor involving the CNS or a major nerve PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Life expectancy More than 3 months Hematopoietic Platelet count ≥ 80,000/mm^3 No sites of ongoing bleeding Hepatic See Disease Characteristics Bilirubin ≤ 1.4 mg/dL AST and ALT ≤ 3 times normal PT or PTT INR ≤ 1.2 Hepatitis B surface antigen negative Hepatitis C virus negative No coagulation disorders Renal Creatinine ≤ 1.6 mg/dL Cardiovascular No ongoing ischemia* No cardiac dysfunction* No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram Pulmonary FEV_1 ≤ 65% of predicted* Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph Other HIV negative No AIDS No systemic infections No other malignancy except carcinoma in situ No psychiatric illness that would preclude study participation or compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy No concurrent steroids Radiotherapy Not specified Surgery Not specified Other More than 28 days since other prior treatment for renal cell cancer No concurrent immunosuppressive agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L. White, MD
Organizational Affiliation
Blumenthal Cancer Center at Carolinas Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States

12. IPD Sharing Statement

Learn more about this trial

High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2

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