Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed under 18 NCI SJCRH-DXDX1-2 NCI-T84-0439D, T84-0439

Objectives

I.  Determine the toxic effects of various dosages of 4'-deoxydoxorubicin in 
pediatric patients with drug-resistant malignant solid tumors.
II.  Determine the maximum tolerated dose of 4'-deoxydoxorubicin in a Phase I 
trial for patients with solid tumors, and extend this information toward the 
completion of a Phase II trial.
III.  Note the antitumor benefits that may follow the administration of 
various dosages of 4'-deoxydoxorubicin.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Pediatric patients with an 
established tissue or marrow diagnosis of drug resistant malignant solid 
tumors.  Measurable indicators of disease activity are not required for the 
Phase I portion, but may include mass lesions, bone lesions, or infiltration 
of the bone marrow; measurable indicators are required for the Phase II 
portion of the study.  Patients may not have received chemotherapy within 2 
weeks of entry, or they must have recovered from the toxic effects of prior 
radiotherapy or chemotherapy prior to entry.  Prior therapy with greater than 
450 mg/sqm of 4'-deoxydoxorubicin excludes.  A life expectancy of at least 8 
weeks and adequate bone marrow (except in patients with thrombocytopenia or 
leukopenia secondary to neuroblastoma or other solid tumors with bone marrow 
infiltration), renal, and hepatic function are required; patients with renal 
or hepatic function abnormalities may be eligible for the Phase II portion if 
pharmacokinetics are to be studied.  There must be clinical, radiographic, 
electrocardiographic, MUGA, and echocardiographic evidence of normal cardiac 
function.

Expected Enrollment

At least 3 patients will be treated at each dosage level.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  4'-Deoxydoxorubicin, DxDx, NSC-267469.

Trial Contact Information

Trial Lead Organizations

St. Jude Children's Research Hospital

Charles Benton Pratt, MD, Protocol chair(Contact information may not be current)		Ph: 901-495-3442 Email: charles.pratt@stjude.org