Status:
WITHDRAWN
S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or ca...
Detailed Description
OBJECTIVES: Primary * Assess the probability of response (confirmed complete and partial responses) in patients with unresectable or metastatic renal cell cancer treated with CNTO 328. Secondary *...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic or unresectable primary renal cell carcinoma
- Measurable disease
- Soft tissue disease within a prior radiation field may be considered measurable disease provided all of the following are true:
- Patient also has measurable disease outside of the irradiated field
- Disease within the irradiated field has progressed since prior radiotherapy
- Radiotherapy was completed more than 2 months ago
- Ineligible for high-dose interleukin-2
- No treated or untreated brain metastases
- No history of brain metastases
- Patients with clinical evidence of brain metastases must have brain CT scan or MRI negative for metastatic disease within 56 days prior to study entry
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine clearance ≥ 40 mL/min
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- SGOT ≤ 3 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No more than 2 of the following:
- Zubrod PS 2
- Lactate dehydrogenase \> 1.5 times ULN
- Hemoglobin \< lower limit of normal
- Calcium \> 10 mg/dL
- Absence of prior nephrectomy
- No uncontrolled intercurrent illness, including any of the following:
- Uncontrolled diabetes mellitus
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
- No HIV positivity
- No other prior malignancy, excluding the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer for which the patient is currently in complete remission
- Any other cancer for which the patient has been disease free for 5 years
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 28 days since prior tumor resection and recovered
- No prior immunotherapy or chemotherapy regimens with interferon (IFN) and/or interleukin-2 (IL-2) or the combination of IFN/IL-2
- No prior cytotoxic chemotherapy for renal cell cancer
- No prior murine or chimeric proteins or human/murine recombination products (i.e., other chimeric monoclonal antibodies)
- No concurrent radiotherapy or systemic therapy for renal cell cancer
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00311545
Last Update
February 20 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.