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Childhood Chronic Myelogenous LeukemiaPhase 1NCT00093821

Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors

A Phase 1 study testing tanespimycin, pharmacological study and laboratory biomarker analysis in people with Childhood Chronic Myelogenous Leukemia and Childhood Desmoplastic Small Round Cell Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of tanespimycin in treating young patients with recurrent or refractory leukemia or selected solid tumors. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
tanespimycin, pharmacological study and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
Sep 2004to Aug 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologically confirmed diagnosis of 1 of the following malignancies:
  • Leukemia
  • Lymphoid, myeloid, or mixed lineage
  • Relapsed (in second or greater relapse) or refractory disease, confirmed by 1 of the following:
  • Bone marrow relapse, defined as either M3 bone marrow (> 25% blasts in the bone marrow aspirate) OR M2 bone marrow (5-25% blasts in the bone marrow aspirate) at any time after complete remission is attained
  • CNS relapse, defined as at least 5 WBC/mL by cytospin of any cerebrospinal fluid (CSF) specimen OR less than 5 WBC/mL by cytospin of 2 consecutive CSF specimens obtained >= 4 weeks apart and having definitive confirmation that blasts are derived from the original leukemic clone by molecular cytogenetics, multiparameter flow cytometry, or immunostaining of >= 2 antigens
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  • Patients with underlying chronic myeloid leukemia must have > 25% blasts in the bone marrow aspirate
  • Patients with M3 bone marrow AND extramedullary sites of disease, other than leptomeningeal disease, are eligible
  • Solid tumor
  • One of the following tumor types:
  • Neuroblastoma
  • Ewing's sarcoma
  • Osteosarcoma
  • Desmoplastic small round cell tumor
  • Rhabdomyosarcoma
  • Progressed after prior standard therapy OR no effective standard therapy exists
  • Measurable or nonmeasurable disease
  • No known brain metastases
  • No active leptomeningeal leukemia, defined by the following criteria:
  • WBC > 5/mm^3 in cerebrospinal fluid (CSF)
  • Unequivocal confirmation of leukemic blasts in CSF by cell morphology
  • No symptomatic CNS disease (e.g., cranial nerve abnormalities) without cytologic abnormality in CSF
  • Performance status - Karnofsky 70-100% (for patients > 10 years of age)
  • Performance status - Lansky 70-100% (for patients =< 10 years of age)
  • More than 8 weeks
  • Absolute neutrophil count >= 750/mm^3
  • Platelet count >= 75,000/mm^3 (transfusion independent)
  • Hemoglobin >= 8.5 g/dL (transfusion allowed)
  • Bilirubin < 1.5 mg/dL
  • ALT and AST =< 2.5 times upper limit of normal (ULN)
  • INR =< 1.5 times ULN
  • Albumin > 2.0 g/dL
  • Creatinine =< 1.5 times ULN for age
  • Creatinine clearance or radioisotope glomerular filtration rate > 60 mL/min
  • Ejection fraction >= 50%
  • Shortening fraction >= 28%
  • QTc < 450 msec for men (470 msec for women)
  • No congenital long QT syndrome
  • LVEF > 40% by MUGA
  • No symptomatic congestive heart failure
  • No cardiac arrhythmia
  • No New York Heart Association class III or IV heart failure
  • No myocardial infarction within the past year
  • No uncontrolled dysrhythmias
  • No poorly controlled angina
  • More than 12 months since active ischemic heart disease
  • No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)
  • No left bundle branch block
  • No other significant cardiac disease
  • No pulmonary fibrosis by radiography
  • No ongoing or active bacterial or fungal infection
  • No other uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • No history of serious allergic reaction attributed to eggs or dimethyl sulfoxide
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Recovered from all immunotherapy
  • At least 6 months since prior allogeneic stem cell transplantation
  • At least 3 months since prior autologous stem cell transplantation
  • At least 2 weeks since prior biologic agents (e.g., monoclonal antibodies)
  • At least 1 week since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Recovered from all prior chemotherapy
  • At least 2 weeks since prior chemotherapy (for patients with leukemia only)
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) (for patients with solid tumors)
  • No prior oxaliplatin
  • No concurrent corticosteroids except for the treatment of adrenal crises in patients with suppressed hypothalamic-pituitary-adrenal axis response OR for treatment of allergic reactions to medications or blood products
  • Recovered from all prior radiotherapy
  • At least 6 months since prior radiotherapy to >= 50% of the pelvis
  • At least 6 months since prior radiotherapy to substantial bone marrow, including total body irradiation
  • At least 4 weeks since prior local (small port) radiotherapy
  • No prior radiotherapy to the heart
  • At least 1 week since prior retinoids
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent medication to control arrhythmias
  • No concurrent medications that prolong or may prolong QTc interval
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Multicenter Phase I Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) in Patients With Recurrent/Refractory Pediatric Solid Tumors (Ewing's Sarcoma, Desmoplastic Small Round Cell Tumor, Osteosarcoma, Neuroblastoma, and Rhabdomyosarcoma) and Leukemia

This phase I trial is studying the side effects and best dose of tanespimycin in treating young patients with recurrent or refractory leukemia or selected solid tumors. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop cancer cells from dividing so they stop growing or die.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the dose-limiting toxicity and maximum tolerated dose (MTD) of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in pediatric patients with recurrent or refractory leukemia or selected solid tumors.

II. Determine the levels of key proteins known to influence cancer cell survival and proliferation in patients treated with this drug at the MTD.

SECONDARY OBJECTIVES:

  1. Determine the pharmacokinetics of this drug in these patients. II. Evaluate effects of genetic polymorphisms known to alter the activity of enzymes involved in the metabolism of this drug.

III. Correlate the alteration of fludeoxyglucose F18 accumulation with tumor response in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (leukemia vs solid tumor).

Patients receive tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11 (for patients with solid tumors) OR days 1, 4, 8, 11, 15, and 18 (for patients with leukemia). Courses for all patients repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of tanespimycin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the MTD.

Patients are followed for 30 days.

Being tested
tanespimycin, pharmacological study, laboratory biomarker analysis
Medical subject headings
Desmoplastic Small Round Cell Tumor, Neuroectodermal Tumors, Primitive, Peripheral, Osteosarcoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tanespimycinDrug

    Also called 17-AAG

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00093821
Study groupRoleWhat they receive
Treatment (tanespimycin)ExperimentalPatients receive tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11 (for patients with solid tumors) OR days 1, 4, 8, 11, 15, and 18 (for patients with leukemia). Courses for all patients repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tanespimycin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the MTD.
Receives: Drug: tanespimycin; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD, defined as the highest dose level with an observed incidence of DLT in no more than 1 out of 6 patients treated at a particular dose level

    Measured: 21 days

Secondary outcomes (1)

  1. Change in Hsp90 client protein levels in relation to dose of tanespimycin

    Measured: Baseline to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093821
Sponsor's protocol ID
NCI-2012-01456
Other IDs
04-069, POETIC-MSKCC-04069, CDR0000391010, NCI-6323, MSKCC-04069, U01CA069856
Status last verified
Jun 2013
First submitted
6 Oct 2004
Last updated
4 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tanespimycin, pharmacological study and laboratory biomarker analysis in people with Childhood Chronic Myelogenous Leukemia and Childhood Desmoplastic Small Round Cell Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 78 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD, defined as the highest dose level with an observed incidence of DLT in no more than 1 out of 6 patients treated at a particular dose level (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00093821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.

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