Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00349167 |
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: PR-104 Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled |
Official Title: | A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Every 3 Weeks in Patients With Solid Tumors |
Estimated Enrollment: | 30 |
Study Start Date: | February 2006 |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter, open-label, prospective, uncontrolled, dose-escalation study.
Patients receive PR-104 IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PR-104 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Blood is collected at baseline and then periodically during study treatment for pharmacokinetic and tumor marker studies. Patients undergo fludeoxyglucose F 18 positron emission tomography scanning before beginning study treatment and after completion of course 2 to assess metabolic activity of the tumor.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No significant cardiac comorbidity including any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month
No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Principal Investigator: | Mark D. Pegram, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000480394, UCLA-0512034-01A, PROACTA-PR-104-1001 |
Study First Received: | July 5, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00349167 |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |