Irinotecan in Tumors and Lymphomas - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Irinotecan

Detailed Description

Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas.

Temozolomide is given by mouth one hour prior to each daily irinotecan dose days 1-5 of each cycle. 100 mg/m2/day. Irinotecan is given IV in dose escalation (minimum of 3 and up to 6 patients per cohort) starting at 15 mg/m2/day daily for 5 days for 2 weeks. Vincristin is given IV 1.5 mg/m2/dose (max dose 2mg) days 1 and 8 of each cycle. Vantin is given 10 mg/kg/day divided in 2 oral doses (max dose 400 mg/day) started 48 hours prior to the start of each treatment cycle and continued for 48 hours after last irinotecan dose. Cycle repeated every 28 days.

Therapy will continue for a minimum of two cycles unless there is progression of disease or unacceptable toxicity and may be continued as long as patient tolerates therapy and there is continued disease control up to one year of therapy.

Study Type

Interventional

Enrollment

40

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Health Sciences Center-Jimmy Everest Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Under age 21 years at time of study entry
Malignant solid tumor, including CNS tumors and lymphomas
Recurrent or refractory disease not amenable to other potentially curative therapies
At least three weeks since last myelosuppressive chemotherapy > 6 months from allogeneic stem cell transplant
Adequate renal and hepatic function
Adequate peripheral blood counts unless bone marrow is involved

Exclusion Criteria:

Patients with leukemia not eligible
Patients with uncontrolled infection excluded
Patients who have received more than 4 prior chemotherapies
Patients who are receiving P450 enzyme-inducing anticonvulsants
Patients who are receiving any other cancer chemotherapy or any other investigational agent
Possible pregnancy will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.
Evaluate feasibility of repetitive cycles of this combination .

Secondary Outcome Measures

Outcome Measure
Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

Principal Investigator: William H Meyer, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria