Temsirolimus-RCC-imaging

NCT01246817 | Unknown Phase 2 DMC

• 1 other identifier: UMCNONCO200903
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses one trialdrug: Temsirolimus (sometimes called Torisel ® ). Temsirolimus is an mTOR inhibitor. It is an agent that is specifically aimed at disrupting cell division (needed for cancer cell growth). Temsirolimus has been shown to inhibit the growth of cancer cells. For patients with metastatic kidney cancer Temsirolimus is now a registered , conventional therapy. It has been recorded for patients as they get renal cell cancer metastases and which looks as if the tumor is aggressive. This is a phase II trial. This means that the investigators look at how effectively temsirolimus is, after treatment with other drugs against kidney cancer. Effective means that the investigators see how well the treatment is, the investigators look at how long the disease is not growing and if it does, that is smaller. The possible side effects will be carefully watched.

Conditions

Renal Cell Cancer

Keywords

Carcinoma, Renal Cell; temsirolimus; FLT-PET; FDG-PET; Adult patients with metastatic RCC (any histology and any MSKCC prognostic score), with documented; progressive disease after more than two prior systemic treatments with any of the following: cytokines (±; chemotherapy), sunitinib, sorafenib, or bevacizumab (± IFN).

Outcome Measures

Primary Outcomes (1)

• Evaluation of the FLT-PET and FDG-PET

  Measurement of 18F-FLT-PET-signal and FDG-PET-signal (ROI analysis and SUVmax calculation), and signal changes during treatment with temsirolimus (percentage change in SUVmax) Correlation of 18F-FLT-PET and FDG-PET before, and signal changes during treatment with treatment outcome (clinical response and PFS).

  before and during treatment

Secondary Outcomes (4)

• Progression free survival

  after treatment

• response rate

  during the trial

• Toxicity

  during and after the trial

• Correlation of pharmacodynamics with PET results

  baseline, after 2nd Temsirolimus infusion after the 6th temsirolimus infusion (approx 5 days after), at time of PD and 2 weeks after the last Temsirolimus infusion

Interventions

Temsirolimus DRUG

temsirolimus (standard schedule: 25 mg weekly, by 1-hour i.v. infusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have received at least one prior angiogenesis inhibitor for their disease.
• Karnofsky performance status ≥ 70.
• At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter ≥ 10-mm when measured by spiral computerized tomography (CT, 5-mm slice thickness contiguous)
• Age ≥ 18 years.
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500 cells/mm3), platelet count ≥ 100 x 109/ L (100,000 cells/ mm3), hemoglobin ≥ 8.0 g/dL (5.0 mmol/L).
• Adequate renal function (serum creatinine ≥ 1.5 times the ULN) or creatinin clearance of ≥ 50 ml/min
• Adequate hepatic function (bilirubin ≤ 1.5 times the ULN, aspartate transaminase (AST) ≤ 3 times the ULN \[≤ 5 times the ULN if liver metastases are present\]).
• Fasting serum cholesterol ≤ 350 mg/dL (9.0 mmol/L), triglycerides ≤ 400 mg/dL (4.56 mmol/ L).
• Subjects receiving cytochrome P450 (CYP) 3A4 inducers or inhibitors must be on stable doses for at least 1 week prior to randomization.
• Life expectancy of at least 8 weeks.
• Negative pregnancy test for female patients of childbearing potential
• Women and men enrolled into this trial must use adequate birth control measures during the course of the trial and must continue for 3 months after the last dose of temsirolimus.
• Signed and dated written informed consent form

You may not qualify if:

• Subjects with central nervous system (CNS) metastases. Subjects with a prior history of CNS metastases will be eligible if the screening magnetic resonance imaging (MRI)/CT (with contrast) indicates no residual disease.
• Prior investigational therapy/agents within 2 weeks of randomization.
• Prior treatment with a mTOR inhibitor
• History of other prior malignancy in past 5 years, other than basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• Not recovered from prior surgery and/or surgery or radiation therapy within 4 weeks of randomization.
• Immunocompromised subjects, including subjects known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
• Active infection or serious intercurrent illness.
• Presence of unstable angina or myocardial infarction within the previous 6 months (prior to screening), use of ongoing maintenance therapy for life-threatening arrhythmia, known pulmonary hypertension, or pneumonitis.
• Pregnant or nursing women, women who are of childbearing potential who are not using an effective contraceptive method, or men with partners of childbearing potential who are not using an effective contraceptive method. (A woman of childbearing potential is defined as a woman who is biologically capable of becoming pregnant.)
• Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Centre Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• C.M.L. van Herpen, Md PhD

  University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C.M.L. van Herpen, Md PhD

CONTACT

+31 24 361 03 53; c.vanherpen@onco.umcn.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2012
• Last Updated: April 11, 2012

Record last verified: 2012-04

Locations

NL (1)