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TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA


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

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Trial Information

TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA


OBJECTIVES:

- Evaluate the response and disease-free survival of patients with metastatic renal cell
carcinoma treated with subcutaneous interleukin-2 and interferon alfa.

- Assess the toxicity of this regimen.

OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor
burden.

All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of
week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5
of weeks 2-6. Patients are assessed for response approximately 2 months after initiating
therapy. Patients with stable or responding disease undergo a second course; those who
continue to respond may receive additional therapy provided toxicity is limited.

Patients are followed for survival.

PROJECTED ACCRUAL: 14 patients will be entered.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven renal cell cancer that is metastatic

- No greater than 50% estimated hepatic replacement by tumor on CT or MRI

- No symptomatic involvement of the CNS or a major nerve

- Measurable disease required

- Ineligible for treatment with low-dose interleukin-2 on another CMC protocol

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 50%-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- No coagulopathy (i.e., platelet count less than 80,000/mm3)

Hepatic:

- AST and ALT no greater than 5 times normal

Renal:

- Creatinine less than 4.0 mg/dL

Cardiovascular:

- No symptomatic angina

- No untreated coronary artery disease

- No refractory arrhythmia

- No abnormal left ventricular function

Pulmonary:

- No dyspnea on minimal exertion

Other:

- No site of ongoing bleeding

- No systemic infection

- No HIV antibody

- No HBsAg

- No requirement for steroids

- No psychiatric disease that precludes informed consent or protocol treatment

- No second malignancy except:

- Basal cell skin carcinoma

- Carcinoma in situ of the cervix

- Not pregnant or nursing

- Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior interleukin-2

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- At least 28 days since prior treatment for renal cell cancer

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:

CDR0000065086

NCT ID:

NCT00002847

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

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