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AzTrials

LeukemiaPhase 1NCT00100997

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate

A Phase 1 study testing tanespimycin in people with Leukemia, run by Jonsson Comprehensive Cancer Center 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

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
tanespimycin
How many people
Not given
Where
1 siteUnited States
Study dates
Oct 2004to Oct 2006
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic phase chronic myelogenous leukemia
  • Philadelphia chromosome (Ph)-positive disease
  • Hematologic resistence after treatment with imatinib mesylate (400 mg per day or maximum tolerated dose [MTD]) as defined by 1 of the following criteria:
  • Loss of complete hematologic response, defined as WBC count OR platelet count > upper limit of normal (ULN) on 2 separate occasions at least 2 weeks apart that cannot be attributed to other etiologies
  • Absolute increase of ≥ 30% in Ph-positive cells while on a stable dose of imatinib mesylate for at least 6 months* NOTE: *Patients meeting this criterion are not eligible for enrollment into the expanded MTD cohort
  • Less than 15% blasts in peripheral blood or bone marrow AND < 30% blasts and promyelocytes in peripheral blood or bone marrow

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin < 1.5 times ULN (3 mg/dL for patients with Gilbert's syndrome)
  • ALT or AST < 2 times ULN
  • No known hepatitis positivity

Renal

  • Creatinine < 1.5 times ULN OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No New York Heart Association class III or IV cardiac disease

Pulmonary

  • No severe debilitating pulmonary disease, including any of the following:
  • Dyspnea at rest
  • Significant shortness of breath
  • Chronic obstructive pulmonary disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study participation
  • No known HIV positivity
  • No psychological or social condition that would preclude study compliance
  • No addictive disorder that would preclude study compliance
  • No family problems that would preclude study compliance
  • No known allergy or sensitivity to soy or other excipient components of study drug
  • No other illness or condition that may affect safety of study treatment or evaluation of study endpoints

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior interferon
  • No concurrent interferon

Chemotherapy

  • More than 2 weeks since prior cytarabine (4 weeks for doses > 100 mg)
  • More than 6 weeks since prior busulfan
  • No concurrent cytarabine
  • No concurrent hydroxyurea during the second study treatment course and beyond
  • No concurrent anagrelide during the second study treatment course and beyond

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 2 days since prior imatinib mesylate
  • More than 1 week since prior and no concurrent drugs that alter metabolism by cytochrome P450 3A4, including the following:
  • Diltiazem
  • Nifedipine
  • Verapamil
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Lovastatin
  • Simvastatin
  • Indinavir
  • Nelfinavir
  • Ritonavir
  • Alprazolam
  • Diazepam
  • Midazolam
  • Triazolam
  • Phenobarbital
  • Phenytoin
  • Carbamazepine
  • Azithromycin
  • Clarithromycin
  • Erythromycin
  • Rifampin
  • Rifamycin
  • Astemizole
  • Terfenidine
  • Amiodarone
  • Cimetidine
  • Cisapride
  • Cyclosporine
  • Grapefruit juice
  • Hypericum perforatum (St. John's wort)
  • Warfarin
  • More than 4 weeks since prior investigational drugs and recovered
  • No concurrent imatinib mesylate

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CNF1010 )17-(Allylamino)-17-Demethoxygeldanamycin [17-AAG]) in Patients With Gleevec-Resistent Chronic Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic myelogenous leukemia that did not respond to imatinib mesylate.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), in terms of frequency, severity, and duration of treatment-emergent adverse events, in patients with imatinib mesylate-resistant Philadelphia chromosome (Ph)-positive chronic phase chronic myelogenous leukemia.
  • Determine the pharmacokinetics of this drug and its primary metabolite (17-amino-17-demethoxygeldanamycin) in these patients.

Secondary

  • Determine the hematologic response rate, in terms of WBC count, platelet count, and assessment of blast cells in peripheral blood, in patients treated with this drug.
  • Determine the cytogenic response rate, in terms of Ph-positive progenitor cells in the bone marrow, in patients treated with this drug.
  • Assess the effect of this drug on pharmacodynamic markers (i.e., CRKL phosphorylation, BCR-ABL kinase activity, and BCR-ABL, RAF kinase, and HSP70 expression) in these patients.

OUTLINE: This is an open label, dose-escalation, multicenter study.

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 15 minutes or 1 hour (depending on the dose administered) once on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for up to 3 courses in the absence of unacceptable toxicity or disease progression. Eligible patients may receive additional courses of 17-AAG at the discretion of the investigator.

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 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients are treated at the MTD.

Patients are followed for 1 month.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Conditions
Leukemia
Being tested
tanespimycin
Keywords
chronic myelogenous leukemia, BCR-ABL1 positive, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia
Medical subject headings
Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

What participants receive

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

  • tanespimycinDrug

Timeline

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

  1. First posted10 Jan 2005 (estimated)
  2. Study startOct 2004
  3. Study completionOct 2006

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
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00100997
Sponsor's protocol ID
UCLA-0408048-01
Other IDs
CDR0000407499, CTC-CNF1010, CTC-CNF1010-CML-04001
Status last verified
May 2005
First submitted
7 Jan 2005
Last updated
10 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tanespimycin in people with Leukemia, run by Jonsson Comprehensive Cancer Center 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?

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 10 Jul 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.

Where can I read the original study information?
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 10 Jul 2013.

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