Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT00222443

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphomas Tumors	Drug: Irinotecan	Phase 1

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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