Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Imatinib Mesylate; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed clear cell kidney cancer, meeting 1 of the following criteria:

• Measurable metastatic disease

• Locally unresectable disease

• No history of known brain metastases that have not been adequately treated with radiotherapy and/or surgery

• Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal cell carcinoma

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Absolute neutrophil count > 1,500/mm³

• Platelet count > 100,000/mm³

• Hemoglobin > 8 g/dL

• Bilirubin < 1.5 times upper limit of normal (ULN)

• Serum glutamic oxaloacetic transaminase(SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 2.5 times ULN

• Creatinine < 1.5 times ULN

• No New York Heat Association grade III-IV cardiac disease

• No other malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or insignificant or inactive disease

• No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

• No severe or uncontrolled medical disease

• No gastrointestinal disease or impairment that would hinder the absorption of everolimus

• No uncontrolled diabetes

• No chronic renal disease

• No active uncontrolled infection

• No congestive heart failure

• No myocardial infarction within the past 6 months

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 2 weeks since prior major surgery

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin C)

• More than 4 weeks since prior immunotherapy

• More than 4 weeks since other prior investigational agents

• No prior radiotherapy to > 25% of bone marrow

• No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor

• No concurrent therapeutic warfarin