Suspended

Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+13

+ Adenocarcinoma
+ Carcinoma
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 1998
See protocol details

Summary

Principal SponsorBlumenthal Cancer Center at Carolinas Medical Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 1998Actual date on which the first participant was enrolled.

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.

Official TitleTreatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2 
NCT00080977
Principal SponsorBlumenthal Cancer Center at Carolinas Medical Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Adenocarcinoma
Carcinoma
Carcinoma, Renal Cell
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Female Urogenital Diseases
Male Urogenital Diseases
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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, United StatesSee the location
SuspendedOne Study Center