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
  Purpose

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 Intervention Phase
Lymphomas
Tumors
Drug: Irinotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

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.

Estimated Enrollment: 40
Study Start Date: September 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222443

Locations
United States, Oklahoma
Oklahoma University Health Sciences Center-Jimmy Everest Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: William H Meyer, MD University of Oklahoma
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00222443     History of Changes
Obsolete Identifiers: NCT00277719
Other Study ID Numbers: JEC Toca One
Study First Received: September 20, 2005
Last Updated: September 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Recurrent solid tumors
recurrent lymphomas
Pediatrics
Adolescents

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014