Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	CMC-10-01-01AH NCT00080977

Objectives

1. 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.
2. Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.
3. Determine the toxicity of this drug in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 80-100%

Life expectancy

• More than 3 months

Hematopoietic

• Platelet count ≥ 80,000/mm³
• 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

• FEV₁ ≤ 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

Expected Enrollment

A total of 20 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Blumenthal Cancer Center at Carolinas Medical Center

Richard White, MD, Protocol chair		Ph: 704-355-2884

Registry Information
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
Trial Start Date		1998-06-16
Registered in ClinicalTrials.gov		NCT00080977
Date Submitted to PDQ		2004-02-18
Information Last Verified		2005-06-23

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