Status:
COMPLETED
A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neoplasm
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 potent...
Detailed 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 potent...
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.
Key Trial Info
Start Date :
September 1 1993
Trial Type :
INTERVENTIONAL
End Date :
June 1 2001
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00001341
Start Date
September 1 1993
End Date
June 1 2001
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892