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AzTrials

LeukemiaPhase 1/2NCT00030355

Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

A Phase 1/2 study testing homoharringtonine and chemotherapy in people with Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Leukemia
What is being tested?
homoharringtonine and chemotherapy
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Phase 1/2
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of acute promyelocytic leukemia confirmed morphologically and by t(15;17) translocation or molecular polymerase chain reaction
  • Refractory to tretinoin, anthracyclines, and arsenic-based therapy (including arsenic trioxide) and for which no other alternative therapy of higher priority is appropriate

PATIENT CHARACTERISTICS:

Age:

  • 12 and over

Performance status:

  • Zubrod 0-3

Life expectancy:

  • More than 4 weeks

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • ALT no greater than 3 times upper limit of normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No active ischemia
  • No other uncontrolled cardiac condition (e.g., angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure)
  • No myocardial infarction within the past 12 weeks

Other:

  • No other concurrent illness that would preclude study
  • No other active malignancy
  • No uncontrolled active infection
  • No clinically significant screening serum chemistry results unless attributed to acute promyelocytic leukemia
  • No medical or psychiatric condition that would preclude informed consent or study therapy
  • HIV negative
  • HTLV-I and HTLV-II negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior or concurrent leukapheresis allowed

Chemotherapy:

  • See Disease Characteristics
  • At least 15 days since prior systemic chemotherapy unless leukemia progression necessitates early therapy
  • No other concurrent systemic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Recovered from prior therapy
  • At least 15 days since other prior antileukemic therapy unless leukemia progression necessitates early therapy
  • No other concurrent antileukemic therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: A Phase I/II Open-Label Study Of The Intravenous Administration Of Homoharringtonine (CGX-635) Salvage Therapy For The Treatment Of Refractory Acute Promyelocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia.
  • Determine the antileukemic efficacy of this drug in these patients.

OUTLINE: Patients receive remission induction therapy comprising homoharringtonine (HH) IV continuously on days 1-14. Courses repeat every 4 weeks in the absence of unacceptable toxicity until a complete remission (CR) is achieved or the patient fails to respond after 3 courses.

Patients who achieve a CR during induction therapy receive maintenance therapy comprising HH IV continuously on days 1-7. Maintenance treatment repeats every 4 weeks for a total of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

Conditions
Leukemia
Being tested
homoharringtonine, chemotherapy
Keywords
recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, adult acute promyelocytic leukemia (M3), childhood acute promyelocytic leukemia (M3), adult acute myeloid leukemia with t(15;17)(q22;q12)
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Leukemia, Promyelocytic, Acute

What participants receive

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

  • homoharringtonineDrug

  • chemotherapyProcedure or surgery

What is being measured

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

  1. Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events

  2. Efficacy by response to treatment

Secondary outcomes (5)

  1. Pharmacokinetics

  2. Duration of treatment response

  3. Survival

  4. Induction mortality

  5. Hospitalizations

Timeline

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

  1. First posted27 Jan 2003 (estimated)

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 1/2
Primary purpose
Treatment
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030355
Sponsor's protocol ID
CDR0000069158
Other IDs
CHEMGENEX-CGX-635-APL-101, MDA-DM-01265
Status last verified
Sep 2007
First submitted
14 Feb 2002
Last updated
22 Mar 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing homoharringtonine and chemotherapy in people with Leukemia, 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?

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: withdrawn, as of the sponsor's last update on 22 Mar 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events. The study lists 2 primary outcomes in all. 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 NCT00030355.

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 22 Mar 2013.

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