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


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

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Trial Information

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


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.

Inclusion 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

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:

CDR0000065085

NCT ID:

NCT00002846

Start Date:

September 1995

Completion Date:

Related Keywords:

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

Name

Location

Carolinas Medical CenterCharlotte, North Carolina  28232-2861