Clinical trial · Interventional
S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): withdrawal of support for drug supply
Summary
Brief summary (as posted)
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 carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well CNTO 328 works in treating patients with unresectable or metastatic kidney cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNTO 328 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CNTO 328
- description
- CNTO 328, anti-IL-6 monoclonal antibody; 6 mg/kg, IV, q 2wks x 12 cycles (1 cycle = 2 wks)
- interventionNames
- Biological: CNTO 328
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 cancerReferences
Publications (0)
Data not yet available