Clinical trial NCT00080977: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: recurrent renal cell cancer
stage IV renal cell cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Blumenthal Cancer Center at Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Blumenthal Cancer Center at Carolinas Medical Center
name: Richard L. White, MD
role: STUDY_CHAIR
References: