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

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222443
• Other study ID #: JEC Toca One
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2005
• Last updated: September 19, 2008
• Start date: September 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2008
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00277719

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphomas
• Tumors

Intervention

Drug:
• Irinotecan

Locations

Country	Name	City	State
United States	Oklahoma University Health Sciences Center-Jimmy Everest Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.
Primary	Evaluate feasibility of repetitive cycles of this combination .
Secondary	Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.