Advertisement

Topics

Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer

2014-08-27 03:17:36 | BioPortfolio

Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after surgery works in treating patients with metastatic kidney cancer.

Description

OBJECTIVES:

Primary

- Determine if neoadjuvant sunitinib malate can achieve a clinical benefit of 70% or more to the primary renal tumor prior to surgery and adjuvant sunitinib malate in patients with metastatic renal cancer.

Secondary

- Determine the time to radiological progression in these patients.

- Determine the overall survival of these patients.

- Determine the proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate.

- Determine the translational endpoints.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 3 courses. Approximately 2 weeks later, patients undergo a standard radical nephrectomy with lymph node dissection. Beginning at least 2 weeks after surgery, patients receive oral sunitinib malate on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples may be collected periodically for laboratory studies.

After completion of study treatment, patients are followed every 2 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

sunitinib malate, laboratory biomarker analysis, adjuvant therapy, neoadjuvant therapy, therapeutic conventional surgery

Location

Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry
London
England
United Kingdom
EC1M 6BQ

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:36-0400

Clinical Trials [3278 Associated Clinical Trials listed on BioPortfolio]

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread to nea...

Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate befor...

Sunitinib Malate in Treating Patients With Kidney Cancer

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This clinical trial...

Cilengitide and Sunitinib Malate in Treating Patients With Advanced Solid Tumors or Glioblastoma Multiforme

This clinical trial is studying how well giving cilengitide together with sunitinib malate works in treating patients with advanced solid tumors or glioblastoma multiforme. Cilengitide and...

Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase II trial ...

PubMed Articles [25245 Associated PubMed Articles listed on BioPortfolio]

SURGERY POST NEOADJUVANT THERAPY FOR BREAST CANCER: AN ANALYSIS OF 82 PATIENTS TREATED AT A SPECIALIST UNIT IN JOHANNESBURG.

Neoadjuvant therapy in the breast cancer setting not only provides an indication of response to systemic therapy, but also results in tumour downsizing/downstaging, which facilitates breast conservati...

Immune biomarkers predictive for disease-free survival with adjuvant sunitinib in high-risk locoregional renal cell carcinoma: from randomized phase III S-TRAC study.

Adjuvant sunitinib therapy compared with placebo prolonged disease-free survival (DFS) in patients with locoregional high-risk renal cell carcinoma in the S-TRAC trial (ClinicalTrials.gov number, NCT0...

Extending indication of cyclin-dependent kinase 4/6 inhibitors in the adjuvant and neoadjuvant setting.

A burst of recent activity has surrounded the study of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors for the treatment of metastatic breast cancer. The success of these drugs in the metastatic sett...

Adjuvant versus neoadjuvant chemotherapy in triple-negative breast cancer patients with BRCA mutations.

As triple-negative breast cancers are associated with earlier recurrences and poorer survival, optimal treatment of early-stage breast cancer is essential. Several retrospective studies in triple-nega...

Clinical impact of adjuvant radiation therapy delay after neoadjuvant chemotherapy in locally advanced breast cancer.

and Purpose: Post-operative radiation therapy (PORT) is usually indicated for patients with breast cancer (BC) after neoadjuvant chemotherapy (NAC) and surgery. However, the optimal timing to initiati...

Medical and Biotech [MESH] Definitions

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

An enzyme that catalyzes the conversion of (S)-malate and NAD+ to oxaloacetate and NADH. EC 1.1.1.37.

A light-activated enzyme that catalyzes the oxidation of (S)-malate to OXALOACETATE. It is involved in PYRUVATE metabolism and CARBON fixation.

More From BioPortfolio on "Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial