Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer
Brief summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES: Primary * Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma. Secondary * Determine duration of response in patients treated with this regimen. * Determine the tolerance to and toxicity of this regimen in these patients. * Determine the median and progression-free survival of patients treated with this regimen. OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Interventions
BIOLOGICALPEG-interferon alfa-2b
Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
BIOLOGICALGM-CSF
GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle
DRUGthalidomide
200mg daily by mouth
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease * Measurable disease * Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI * Histologic confirmation required if measurable disease is confined to a solitary lesion * The following are not considered measurable disease: * Bone disease only * Pleural or peritoneal metastases * CNS lesions * Irradiated lesions unless disease progression was documented after prior radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * No decompensated liver disease Renal * Creatinine ≤ 2.0 mg/dL Immunologic * No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system * No history of autoimmune disease * No autoimmune hepatitis * No immunosuppressed transplantation recipients Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation * No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range * No severe psychiatric condition or disorder, including suicidal ideation or attempt * No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy Surgery * Not specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year | To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response | time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment. |
| Frequency of Adverse Events Assessed by NCI CTC Version 2 | From the first day of treatment until the end of treatment visit, an average of 6 months |
| Progression-free Survival | From registration until diease progression or death, whichever comes first. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEG-Intron, BM-CSF and Thalidomide PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle
thalidomide: 200mg daily by mouth | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | PEG-Intron, BM-CSF and Thalidomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Response Rate
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Time frame: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
Population: Data for this endpoint was not collected
Secondary
Duration of Response
Time frame: time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Population: Data for this endpoint was not collected
Secondary
Frequency of Adverse Events Assessed by NCI CTC Version 2
Time frame: From the first day of treatment until the end of treatment visit, an average of 6 months
Population: Data for this endpoint was not collected
Secondary
Progression-free Survival
Time frame: From registration until diease progression or death, whichever comes first.
Population: Data for this endpoint was not collected