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

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00222443
First received: September 20, 2005
Last updated: September 19, 2008
Last verified: September 2008

September 20, 2005
September 19, 2008
September 2004
December 2007   (final data collection date for primary outcome measure)
  • Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.
  • Evaluate feasibility of repetitive cycles of this combination .
  • - Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.
  • - Evaluate feasibility of repetitive cycles of this combination .
Complete list of historical versions of study NCT00222443 on ClinicalTrials.gov Archive Site
Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.
- Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.
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Not Provided
 
Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Lymphomas
  • Tumors
Drug: Irinotecan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00222443
JEC Toca One
Not Provided
Not Provided
University of Oklahoma
Not Provided
Principal Investigator: William H Meyer, MD University of Oklahoma
University of Oklahoma
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP