Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
Condition: Renal Cell Cancer; Kidney Cancer
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: Sunitinib Malate
Intervention description: 50 mg by mouth daily for 4 weeks, then 2 weeks off.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Healthy volunteers: No
Keywords: Non-Clear Cell Renal Carcinoma; Non-clear cell renal cell cancer; Renal Cell Cancer; Kidney Cancer; Papillary; Chromophobe; Collecting duct carcinoma; CDC; Renal medullary carcinoma; RMC; Sunitinib Malate; Sutent; SU011248

Summary:

      The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib
      malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The
      safety of sunitinib malate will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed advanced non-clear cell
             of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma
             (CDC), renal medullary carcinoma (RMC), or unclassified. Patients with
             conventional-type renal cell carcinoma who have >/= 20% sarcomatoid component in their
             primary tumor are eligible. Patients who have sarcomatoid features in fine-needle
             aspiration (FNA) or core biopsy of any metastatic site are eligible.

          2. Patients must have measurable disease.

          3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

          4. Patients must have adequate organ and marrow function within 14 days prior to study
             entry as defined: Hemoglobin >/= 9 g/dl, absolute neutrophil count >/=
             1,500/microliter (microL), platelets >/= 100,000/microL, total bilirubin </= 1.5
             mg/dl, AST(SGOT) and/or ALT (SGPT) </= 2.5 X institutional uln, except in known
             hepatic metastasis, wherein may be </= 5 x uln, serum creatinine </= 4 X uln (as long
             as patient does not require dialysis).

          5. Patients must have recovered from any effects of surgery.

          6. Female patients of childbearing potential (not postmenopausal for at least 12 months
             and not surgically sterile) must have a normal plasma beta human chorionic
             gonadotropin (betaHCG) within 24 hours prior to enrolling in the study.

          7. Patients of child fathering or childbearing potential must agree to practice a form of
             medically acceptable birth control while on study (barrier method, hormonal methods,
             etc.).

          8. Patients must give written informed consent prior to initiation of therapy, in keeping
             with the policies of the institution. Patients with a history of major psychiatric
             illness must be judged (by the treating physician) able to fully understand the
             investigational nature of the study and the risks associated with the therapy.

          9. Patients with brain metastases may participate in this trial.

         10. Patients who have had up to two prior systemic therapies are eligible to participate
             in this trial but they should not have had prior Multi-Tyrosine Kinase Inhibitors such
             as sorafenib or sunitinib malate.

        Exclusion Criteria:

          1. No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma
             of any site, or other cancers for which the patient has been adequately treated and
             disease free for 2 years.

          2. Pregnant or lactating women are excluded.

          3. Patients must not be scheduled to receive any experimental drug for MRCC while on
             study. Patients are permitted to be on concomitant bisphosphonates. Patients are
             permitted to receive hematopoietic growth factors according to American Society of
             Clinical Oncology (ASCO) guidelines.

          4. Patients must not have had prior radiotherapy to areas of measurable disease, unless
             they have clearly progressive disease in this site, or there is measurable disease
             outside the area of prior radiation. Radiotherapy, if needed for palliation, must have
             been completed at least 2 weeks prior to enrollment on this study.

          5. Patients may not have any significant medical disease (other than the malignancy)
             that, in the investigator's opinion, would increase the risk for participation.
             Examples of exclusion: unstable angina pectoris, New York Heart Association (NYHA)
             Grade II or greater congestive heart failure, unstable symptomatic cardiac arrhythmias
             requiring medication (subjects with controlled chronic atrial fibrillation are
             eligible), myocardial infarction within 6 months, uncontrolled HTN (blood pressure
             >150/90 on therapy), corrected QT interval (QTc) interval > 500msec or other
             significant ECG abnormalities or uncontrolled DM.

          6. Patients must not have history of other diseases, metabolic dysfunction, physical
             examination finding, or clinical laboratory finding giving reasonable suspicion of a
             disease or condition that contraindicates the use of sunitinib malate or that might
             affect the interpretation of the results of the study or render the subject at high
             risk from treatment complications.

          7. Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine,
             procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and
             indapamide) is not recommended.

          8. Patients unwilling to participate or unable to comply with the protocol for the
             duration of the study.