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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

Primary Purpose

Acute Undifferentiated Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tanespimycin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Undifferentiated Leukemia

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • COG Phase I Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

MTD defined as the maximum dose at which fewer than one-third of patients experience DLT

Secondary Outcome Measures

Full Information

First Posted
March 8, 2004
Last Updated
June 3, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00079404
Brief Title
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
Official Title
A Phase I Study of 17-AAG in Relapsed/Refractory Pediatric Patients With Solid Tumors or Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or refractory solid tumors or leukemia. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from dividing so they stop growing or die.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Undifferentiated Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tanespimycin
Other Intervention Name(s)
17-AAG
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
MTD defined as the maximum dose at which fewer than one-third of patients experience DLT
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Weigel
Organizational Affiliation
COG Phase I Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
COG Phase I Consortium
City
Arcadia
State/Province
California
ZIP/Postal Code
91006-3776
Country
United States

12. IPD Sharing Statement

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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

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