Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

aldesleukin

conventional surgery

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent No central nervous system or major nerve involvement No more than 25% estimated hepatic replacement by tumor on CT or MRI Measurable disease required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: Greater than 3 months Hematopoietic: Platelet count at least 80,000/mm3 Hepatic: Bilirubin normal AST and ALT no greater than 3 times normal Renal: Creatinine normal Cardiovascular: Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG) Pulmonary: FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray) Other: No sites of ongoing bleeding No HIV antibody or AIDS No hepatitis B antigen No systemic infection No requirement for steroids No psychiatric disease that precludes informed consent or safe administration of immunotherapy No second malignancy except: Basal cell carcinoma In situ cervical cancer Other cancer provided all evaluable lesions are documented RCC No pregnant or nursing women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy No prior interleukin-2 therapy Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 28 days since therapy for RCC

Sites / Locations

Carolinas Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002846

First Posted

November 1, 1999

Last Updated

December 18, 2013

Sponsor

Blumenthal Cancer Center at Carolinas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00002846

Brief Title

Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

Official Title

TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2

Study Type

Interventional

2. Study Status

Record Verification Date

December 2003

Overall Recruitment Status

Unknown status

Study Start Date

September 1995 (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 kidney cancer cells. PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.

Detailed Description

OBJECTIVES: Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2. Assess the toxicity associated with this treatment. OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited. Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy. Patients are followed for survival. PROJECTED ACCRUAL: A total of 14 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

stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

aldesleukin

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent No central nervous system or major nerve involvement No more than 25% estimated hepatic replacement by tumor on CT or MRI Measurable disease required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: Greater than 3 months Hematopoietic: Platelet count at least 80,000/mm3 Hepatic: Bilirubin normal AST and ALT no greater than 3 times normal Renal: Creatinine normal Cardiovascular: Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG) Pulmonary: FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray) Other: No sites of ongoing bleeding No HIV antibody or AIDS No hepatitis B antigen No systemic infection No requirement for steroids No psychiatric disease that precludes informed consent or safe administration of immunotherapy No second malignancy except: Basal cell carcinoma In situ cervical cancer Other cancer provided all evaluable lesions are documented RCC No pregnant or nursing women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy No prior interleukin-2 therapy Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 28 days since therapy for RCC

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

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28232-2861

Country

United States

Kidney Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial