Know Cancer

or
forgot password

Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma


OBJECTIVES:

- Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell
carcinoma.

- Determine the time to disease progression in patients treated with this drug.

- Determine the safety of this drug in these patients.

- Determine the quality of life of patients treated with this drug.

- Determine the effect of this drug on biological surrogates of antitumor activity (basic
fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum
levels) in these patients.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat
every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after
initiation of study therapy, and then at completion of study therapy.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Metastatic disease

- No prior therapy for advanced disease

- Tumor sample available for molecular analysis with prior registration on MSKCC IRB #
89-076

- Bidimensionally measurable disease

- No brain metastases unless completely resected and without evidence of recurrence for
at least six months

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- WBC at least 3,000/mm3

- Platelet count at least 100,000/mm3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic
metastases)

- Hepatitis B surface antigen negative

- Hepatitis C negative

Renal

- Creatinine no greater than 2 mg/dL

Cardiovascular

- No severe cardiac disease

- No New York Heart Association class III or IV cardiac disease

- No myocardial infarction within the past 12 months

- No ventricular tachyarrhythmias requiring ongoing treatment

- No unstable angina

Pulmonary

- No severe asthma requiring chronic systemic steroids

Other

- HIV negative

- Negative pregnancy test

- Fertile patients must use effective contraception

- No malignancy within the past 2 years except basal cell or squamous cell skin cancer,
superficial bladder cancer, or localized prostate cancer

- Patients who have undergone potentially curative therapy and have been deemed to
be at low risk for recurrence are eligible

- No medically significant psychiatric disease (e.g., endogenous depression, psychosis,
or bipolar disease) requiring hospitalization

- No prior or active autoimmune disease

- Medically controlled diabetes or thyroid dysfunction allowed

- No clinically significant acute viral or bacterial infection that requires specific
therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior interleukin-2

- No prior interferon alfa

- No concurrent cytokines or biological response modifiers except epoetin alfa in the
case of hematologic compromise

- No concurrent tumor vaccines

- No concurrent monoclonal antibodies

- No concurrent bone marrow/stem cell transplantation

Chemotherapy

- No concurrent cytotoxic agents

Endocrine therapy

- No concurrent high-dose systemic steroids

- Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or
intra-articular injections) allowed

- No concurrent hormonal therapy (including megestrol)

- Concurrent hormone replacement therapy or oral contraceptives allowed

Radiotherapy

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- At least 4 weeks since prior major surgery

- Concurrent nephrectomy allowed

Other

- At least 14 days since prior anti-infectious therapy

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-143

NCT ID:

NCT00045279

Start Date:

April 2002

Completion Date:

September 2005

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021