A Phase I Study of 17-AAG in Relapsed/Refractory Pediatric Patients With Solid Tumors or Leukemia
tanespimycin
Hematologic Diseases+9
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and recommended phase II dose of 17-AAG administered as a 60 or 120-minute intravenous infusion on days 1, 4, 8, and 11, of a 21-day course, to children with refractory solid tumors or relapsed leukemia. II. To define and describe the toxicities of 17-AAG administered on this schedule. III. To characterize the pharmacokinetics of 17-AAG in children with refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of 17-AAG within the confines of a phase I study. II. To assess the biologic activity of 17-AAG. III. To examine the role of CYP3A5 polymorphisms in the pharmacologic and clinical phenotypes observed following administration of 17-AAG to children, within the confines of a phase 1 study. OUTLINE: This is a dose-escalation, multicenter study. Patients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-120 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients with leukemia receive 17-AAG at the MTD as above. If these 6 patients tolerate this regimen, another 6 leukemia patients receive 17-AAG IV over 60 minutes on days 1, 4, 8, 11, 15, and 18. Treatment repeats every 28 days for 17 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 to 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of solid tumor or leukemia with documented M3 marrow * Histologic confirmation of intrinsic brain stem tumors not required * Relapsed or refractory disease * No known curative therapy * In patients with CNS tumors, neurologic deficits must be stable for at least the past week * Performance status - Karnofsky 50-100% (\>10 years of age) * Performance status - Lansky 50-100% (≤ 10 years of age) * For patients with solid tumors: * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions) * For patients with leukemia: * Platelet count ≥ 20,000/mm\^3 (may receive platelet transfusions) * Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT ≤ 2.5 times ULN * Albumin ≥ 2 g/dL * Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min * Creatinine based on age as follows: * ≤ 0.8 mg/dL if ≤ 5 years of age * ≤ 1.0 mg/dL if \> 5 years and ≤ 10 years of age * ≤ 1.2 mg/dL if \> 10 years and ≤ 15 years of age * ≤ 1.5 mg/dL if \> 15 years and ≤ 21 years of age * No uncontrolled infection * No prior severe allergy to eggs * No situation that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * At least 7 days (or window for adverse effects has passed) since prior biologic therapy and recovered * At least 7 days since prior hematopoietic growth factors * At least 2 months since prior stem cell transplantation and no evidence of graft-vs-host disease * No concurrent hematopoietic growth factors * No concurrent biologic therapy * No concurrent immunotherapy * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent steroid therapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 3 months since prior total body irradiation or craniospinal radiotherapy * At least 3 months since prior radiotherapy to ≥ 50% of the pelvis * At least 6 weeks since prior substantial bone marrow radiotherapy * Recovered from prior radiotherapy * No concurrent radiotherapy * No other concurrent investigational drugs * No other concurrent anticancer agents * No concurrent phenytoin or phenobarbital * No concurrent warfarin
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location