Search / Trial NCT00001341

A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Antifolate Inhibitor Pharmacokinetics Thymidylate Synthetase Toxicity

Description

Thymidylate synthase (TS), an enzyme which acts by utilizing 5,10-CH(2)FH(4) in the reductive methylation of deoxyuridylate (dUMP), is required for the de novo synthesis of thymidylate and is a potential chemotherapeutic target. ZD1694 is a new quinazolone folate analog that directly inhibits TS. This phase I trial and pharmacokinetic study will describe and define the toxicities, determine the MTD, and describe the plasma pharmacokinetics of ZD1694 in pediatric patients with refractory cancer. The starting dose for this trial will be 2.0 mg/m(2) administered as a 15 minute IV infusion ever...

Gender

All

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Histologically proven malignancy considered refractory to standard therapy. Objective evidence of progression on prior therapy required.
  • No leukemia.
  • Bone marrow involvement by tumor acceptable. Marrow biopsy required if there is a history of involvement or peripheral counts are inadequate.
  • PRIOR/CONCURRENT THERAPY:
  • Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.
  • Chemotherapy: No more than 2 prior chemotherapy regimens and recovered. At least 2 weeks since myelosuppressive therapy (6 weeks since nitrosoureas).
  • Endocrine Therapy: Not specified.
  • Radiotherapy:
  • No prior central axis irradiation (i.e., skull, spine, ribs, pelvis).
  • Recovery from toxic effects of prior radiotherapy required.
  • Surgery: Not specified.
  • Other: No prior bone marrow transplantation.
  • PATIENT CHARACTERISTICS:
  • Age: 21 and under.
  • Performance status: ECOG 0-2.
  • Life expectancy: At least 8 weeks.
  • Hematopoietic:
  • (unless histologic evidence of bone marrow involvement by tumor).
  • AGC at least 1,500/mm3.
  • Platelet count at least 100,000/mm3.
  • Hemoglobin at least 8.0 g/dL.
  • Prior transfusion acceptable.
  • Hepatic:
  • Bilirubin no greater than 2 times normal.
  • ALT no greater than 2 times normal.
  • Renal:
  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min/1.73 sqm.
  • Cardiovascular: Not specified.
  • Pulmonary: Not specified.
  • OTHER:
  • No significant accumulation of third space fluid.
  • No significant systemic illness (e.g., infection).
  • No pregnant or nursing women.
  • Pregnancy test required in fertile women.
  • All patients or their guardians must sign an informed consent.

Attachments

readout_NCT00001341_2024-06-14.pdf

4.5 MB

NCT00001341_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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