Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy with interleukin-2 and GM-CSF may be a more effective treatment for kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2, vinblastine, and GM-CSF in treating patients with metastatic kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2, vinblastine, and GM-CSF in treating patients with metastatic kidney cancer.
Brief Title
Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer
Detailed Description
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.
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.
Categories
Conditions
Kidney Cancer
Eligibility 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
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
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
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
Gender
All
Gender Based
false
Keywords
stage IV renal cell cancer
recurrent renal cell cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00003181
Org Class
Nih
Org Full Name
National Cancer Institute (NCI)
Org Study Id
CDR0000066003
Overall Status
Unknown status
Phases
Phase 2
Official Title
A Phase II Study Using Low Dose Subcutaneous IL-2, Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma
Secondary Ids
Secondary Id
HCRN-002
Secondary Id
NCI-V98-1373
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sandeep Malik
Investigator Email
Investigator Phone
Categories Mesh Debug
Prostate Cancer --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Prostate Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Kidney & Urinary Tract --- KIDNEY DISEASES
Kidney & Urinary Tract --- UROLOGIC DISEASES
Endocrine System Cancers --- ADENOCARCINOMA
Cancer --- CARCINOMA
Lung & Chest Cancers --- NEOPLASMS, GLANDULAR AND EPITHELIAL
Blood & Bone Marrow Cancers --- NEOPLASMS BY HISTOLOGIC TYPE
MeSH Terms
KIDNEY NEOPLASMS
CARCINOMA, RENAL CELL
UROLOGIC NEOPLASMS
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
KIDNEY DISEASES
UROLOGIC DISEASES
MALE UROGENITAL DISEASES
ADENOCARCINOMA
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
ALDESLEUKIN
SARGRAMOSTIM
VINBLASTINE
VINCA ALKALOIDS
SECOLOGANIN TRYPTAMINE ALKALOIDS
INDOLE ALKALOIDS
ALKALOIDS
HETEROCYCLIC COMPOUNDS
INDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
INDOLIZIDINES
INDOLIZINES