Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2003 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on November 1, 1999. Last Updated on February 6, 2009 History of Changes

Sponsor:	Blumenthal Cancer Center at Carolinas Medical Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002847

Purpose

RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.

Condition	Intervention	Phase
Kidney Cancer	Biological: aldesleukin Biological: recombinant interferon alfa Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Interferon alfa-2a Interleukin-2 Aldesleukin Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	14
Study Start Date:	September 1995

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002847

Locations

United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861

Sponsors and Collaborators

Blumenthal Cancer Center at Carolinas Medical Center

Investigators

Study Chair:

Richard L. White, MD

Blumenthal Cancer Center at Carolinas Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00002847 History of Changes
Other Study ID Numbers:	CDR0000065086, CMC-09-95-14B, NCI-V96-1039
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons

Aldesleukin
Interleukin-2
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on February 09, 2012