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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard L. White, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Blumenthal Cancer Center at Carolinas Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000357581

NCT ID:

NCT00080977

Start Date:

June 1998

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861