Know Cancer

or
forgot password

A Phase II Study Using Low Dose Subcutaneous IL-2, Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma


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

Thank you

Trial Information

A Phase II Study Using Low Dose Subcutaneous IL-2, Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma


OBJECTIVES: I. Determine the effect of sargramostim (granulocyte-macrophage
colony-stimulating factor; GM-CSF) in combination with interleukin-2 and vinblastine on the
response rate of patients with metastatic renal cell carcinoma. II. Assess the potential
toxicities of this treatment combination in these patients.

OUTLINE: This is a single arm, nonrandomized study. Patients receive vinblastine as an IV
bolus once every 2 weeks. Interleukin-2 is administered by subcutaneous injection on days
1-5 each week for 9 weeks. Sargramostim (granulocyte-macrophage colony-stimulating factor;
GM-CSF) is administered by subcutaneous injection on days 1-5 each week for 9 weeks. Each 9
week cycle is followed by 3 weeks of rest. Patient may continue treatment for a maximum of 5
cycles in the absence of disease progression. Patients are assessed every 12 weeks for the
duration of treatment.

PROJECTED ACCRUAL: 20-35 patients will be accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven inoperable, metastatic, or recurrent renal
cell carcinoma Measurable or evaluable disease No brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Neutrophil count greater than 1,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Liver enzymes less than 3 (5 if known liver metastases)
times institutional normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Adequate
cardiac function No unstable angina No significant coronary artery disease No heart
failure with New York Heart Association classification III or IV Pulmonary: No evidence of
pulmonary disease (documented normal DLCO and PFT) Other: No prior malignancy except:
Nonmelanoma skin cancer Carcinoma in situ of any kind No pregnant or lactating Fertile
patients must use adequate contraception Normal thyroid functions as evidenced by normal
T4 and TSH

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy At least
4 weeks since prior biologic therapy Chemotherapy: No more than 1 prior chemotherapy At
least 4 weeks since prior chemotherapy Endocrine therapy: No more than 1 prior hormonal
therapy At least 4 weeks since prior hormonal therapy Radiotherapy: At least 4 weeks since
prior radiation therapy No prior radiation therapy if entire tumor was within radiation
field Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Raj Sadasivan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hope Cancer Institute, Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000066003

NCT ID:

NCT00003181

Start Date:

May 1997

Completion Date:

Related Keywords:

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

Name

Location

Bethany Medical CenterKansas City, Kansas  66102
Heartland Cancer Research and Treatment CenterKansas City, Kansas  66106