Temsirolimus In Phase 0

NCT01417065 | Completed Early Phase 1

• 3 other identifiers: 2010-0259NCI-2011-027992K12CA088084-12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested. The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.

Conditions

Advanced Cancer

Keywords

Cancer; mTOR inhibitor Temsirolimus; Torisel; CCI-779; pharmacodynamic targets

Outcome Measures

Primary Outcomes (1)

• Participants' Pharmacodynamic (PD) Responses

  PD response, significant S6 Kinase 1 (S6K1) inhibition, is defined at both the patient level and the dose level, 1) as compared with baseline, at least 50% reductions of S6K1 after treatment (biological criterion); 2) differences in log transformed S6K1 activity between post-treatment and baseline should be greater than threshold of 1.8 times standard deviation (SD) of baseline, which yields a 90% statistical confidence that it is not due to chance variation (statistical criterion).

  Blood drawn at 4 hours (+/- 2 hours) after study drug

Study Arms (1)

Temsirolimus

EXPERIMENTAL

Starting dose 0.02 mg intravenous administered once.

Drug: Temsirolimus

Interventions

Temsirolimus DRUG

Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.

Also known as: CCI-779, Torisel

Temsirolimus

Eligibility Criteria

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

You may qualify if:

• Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy.
• Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, antibody or other biological therapy, whichever is shorter.
• Patients should preferably be undergoing screening for 2007-0668, 2008-0384, 2008-0425, and 2008-0827 (currently active Phase I trials involving temsirolimus). However, patients may also be allowed on protocol if they are undergoing screening for any study.

You may not qualify if:

• Pregnant or lactating women.
• Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
• Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated.
• Patients who are less than 18 years of age.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Interventions

temsirolimus

Study Officials

• Daniel Karp, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2014
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

US (1)