Status:

COMPLETED

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

Lead Sponsor:

University of Oklahoma

Conditions:

Lymphomas

Tumors

Eligibility:

All Genders

1-21 years

Phase:

PHASE1

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 chem...

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 chem...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

December 1 2007

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00222443

Start Date

September 1 2004

End Date

December 1 2007

Last Update

September 22 2008

Active Locations (1)

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Oklahoma University Health Sciences Center-Jimmy Everest Center

Oklahoma City, Oklahoma, United States, 73104