Acute Lymphocytic LeukemiaPhase 1NCT00430443
Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed ALL or AML
A Phase 1 study testing Liposomal Annamycin in people with Acute Lymphocytic Leukemia and Acute Myelogenous Leukemia, run by Callisto Pharmaceuticals at 3 sites in United States.
Trial summary
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. Read more about this study
- Who is it for?
- Ages 12 months to 21 years
- Conditions the study is for
- Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia
- What is being tested?
- Liposomal Annamycin
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Jan 2009
- 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 12 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of refractory or relapsed ALL or AML.
- 12 months to 21 years of age at the time of informed consent.
- Weight ≥10 kg
- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from the toxic side effects of such therapy. In the instance of rapidly progressive disease, anti-leukemia therapy may be administered within the 2-week period as long as the subject has recovered from the toxic effects of that therapy. Also, intrathecal therapy may be administered within the 2-week period for subjects with CNS disease.
- No stem cell transplant regimen within 3 months prior to first dose of study drug.
- No conventional granulocyte colony stimulating factor (G-CSF) within 7 days prior to the first dose of study drug, and no long-acting G-CSF (Neulasta) within 14 days prior to the first dose of study drug.
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- No investigational therapy within 4 weeks prior to first dose of study drug.
- Karnofsky Performance Status ≥50% for subjects ≥10 years of age and Lansky Performance Status ≥60% for subjects <10 years of age. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance status.
- Adequate liver function [bilirubin ≤2 times the upper limit of normal (ULN) and serum glutamic-pyruvic transaminase (SGPT) ≤5 times the ULN].
- Adequate renal function (creatinine clearance ≥60 ml/min/1.73m2).
- Adequate cardiac function [ejection fraction (EF) >50% or shortening fraction (SF) >28% by echocardiogram or MUGA]
- Informed consent signed by subject or legal guardian per investigational site guidelines.
- Able to comply with the requirements of the protocol.
- Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study drug.
- All subjects (male and female) of childbearing potential must agree to practice effective contraception during the entire study period, unless documentation of infertility exists. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- Concomitant therapy that includes other chemotherapy that is or may be active against ALL or AML, except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents. Concurrent radiation therapy and immunosuppressive therapy are not allowed. Concurrent intrathecal therapy per standard of care is allowed for subjects with CNS disease.
- Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (≤6 months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements. Cardiac patients with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded.
- Active graft-versus-host disease (GVHD).
- Pregnant, lactating, or not using adequate contraception.
- Known allergy to doxorubicin or anthracyclines.
- Any evidence of mucositis/stomatitis, except for Grade 1 mucositis/stomatitis due to chronic GVHD.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Denver Children's Hospital
Denver, Colorado, 80218
Vanderbilt Children's Hospital
Nashville, Tennessee, 37237
Phoenix Children's Hospital
Phoenix, Arizona, 85016
About this study
Official title: Phase I Study of Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed Acute Lymphocytic Leukemia and Acute Myelogeneous Leukemia
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.The primary objectives of this study are 1) to evaluate the safety and identify the maximum tolerated dose (MTD) of liposomal annamycin when given in 3 consecutive daily doses, starting at 130 mg/m2/day and ranging to as high as 310 mg/m2/day, or the MTD, whichever is lower, in children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML), and 2) to evaluate the antileukemic activity of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. The secondary objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Read the detailed description
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.
The initial group of 3 subjects will receive a treatment cycle of 130 mg/m2/day liposomal annamycin daily for 3 consecutive days followed by 18 days off liposomal annamycin (i.e., 1 treatment cycle = 21 days). A prophylactic mouthwash for use with anthracyline-based chemotherapies (composition described below under Test Product, Dose, and Mode of Administration) will be used 4 times a day on Days 1-4, with one of the 4 times being immediately 1 hour prior to liposomal annamycin treatment on Days 1 3, to prevent oral mucositis. Anti-allergic pre-medication with diphenydramine will be administered before each dose of liposomal annamycin.
Provided that no subject experiences dose limiting toxicity (DLT) [defined as a study drug related Grade 3 or higher non-hematologic toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0] during the first 21 days (i.e., during the first treatment cycle), the subsequent group of 3 subjects will receive the next higher liposomal annamycin dose. However, if 1 of the 3 initial subjects experiences DLT, the cohort of subjects at the initial dose level will be expanded to 6 subjects. If at least 2 of the 6 subjects experience DLT, then 3 subjects will be treated at the next lower dose. The MTD is defined as the highest dose of liposomal annamycin at which fewer than 2 (of a cohort of up to 6) subjects experience a DLT.
Subsequent dose escalation will occur in a similar fashion. If a subject discontinues treatment for reasons other than study drug related adverse events such that safety cannot be fully evaluated, an additional subject may be enrolled; these will be reviewed on a case-by-case basis in conjunction with the Sponsor. The dose will be escalated until either a MTD is identified or the maximum dose, 310 mg/m2/day, is achieved. Ten additional subjects will be enrolled at the MTD to better define toxicity and to better evaluate efficacy at the MTD.
Subjects will be evaluated before the start of liposomal annamycin treatment and during the first 3 days of liposomal annamycin treatment. Subjects will be evaluated weekly thereafter during the first cycle of treatment (1 cycle consists of 3 weeks, with 3 consecutive days of daily liposomal annamycin treatment followed by 18 days off of liposomal annamycin) and weekly during each subsequent cycle that they are eligible to receive further treatment. A follow-up visit will be conducted 1 to 2 weeks after the final treatment cycle or after the last study drug administration, if the treatment period was prematurely terminated.
- Being tested
- Liposomal Annamycin
- Keywords
- Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia, Annamycin, Liposomal Annamycin
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal AnnamycinDrug
3-day IV infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and identify the MTD of liposomal annamycin and to evaluate the antileukemic activity of liposomal annamycin in children and young adults.
Measured: 8 months
Secondary outcomes (1)
To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionJan 2009
Why it stopped: Participants are no longer being examined or treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Callisto Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Jacob, Ph.D., Study director, Callisto Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430443
- Sponsor's protocol ID
- CP-105
- Status last verified
- Aug 2011
- First submitted
- 30 Jan 2007
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed Acute Lymphocytic Leukemia and Acute Myelogeneous Leukemia
- ClinicalTrials.gov ID
- NCT00430443
- Acronym / sponsor ID
- CP-105
- Keywords
- Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia, Annamycin, Liposomal Annamycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants are no longer being examined or treated.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Callisto PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.The primary objectives of this study are 1) to evaluate the safety and identify the maximum tolerated dose (MTD) of liposomal annamycin when given in 3 consecutive daily doses, starting at 130 mg/m2/day and ranging to as high as 310 mg/m2/day, or the MTD, whichever is lower, in children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML), and 2) to evaluate the antileukemic activity of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. The secondary objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Detailed description
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.
The initial group of 3 subjects will receive a treatment cycle of 130 mg/m2/day liposomal annamycin daily for 3 consecutive days followed by 18 days off liposomal annamycin (i.e., 1 treatment cycle = 21 days). A prophylactic mouthwash for use with anthracyline-based chemotherapies (composition described below under Test Product, Dose, and Mode of Administration) will be used 4 times a day on Days 1-4, with one of the 4 times being immediately 1 hour prior to liposomal annamycin treatment on Days 1 3, to prevent oral mucositis. Anti-allergic pre-medication with diphenydramine will be administered before each dose of liposomal annamycin.
Provided that no subject experiences dose limiting toxicity (DLT) [defined as a study drug related Grade 3 or higher non-hematologic toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0] during the first 21 days (i.e., during the first treatment cycle), the subsequent group of 3 subjects will receive the next higher liposomal annamycin dose. However, if 1 of the 3 initial subjects experiences DLT, the cohort of subjects at the initial dose level will be expanded to 6 subjects. If at least 2 of the 6 subjects experience DLT, then 3 subjects will be treated at the next lower dose. The MTD is defined as the highest dose of liposomal annamycin at which fewer than 2 (of a cohort of up to 6) subjects experience a DLT.
Subsequent dose escalation will occur in a similar fashion. If a subject discontinues treatment for reasons other than study drug related adverse events such that safety cannot be fully evaluated, an additional subject may be enrolled; these will be reviewed on a case-by-case basis in conjunction with the Sponsor. The dose will be escalated until either a MTD is identified or the maximum dose, 310 mg/m2/day, is achieved. Ten additional subjects will be enrolled at the MTD to better define toxicity and to better evaluate efficacy at the MTD.
Subjects will be evaluated before the start of liposomal annamycin treatment and during the first 3 days of liposomal annamycin treatment. Subjects will be evaluated weekly thereafter during the first cycle of treatment (1 cycle consists of 3 weeks, with 3 consecutive days of daily liposomal annamycin treatment followed by 18 days off of liposomal annamycin) and weekly during each subsequent cycle that they are eligible to receive further treatment. A follow-up visit will be conducted 1 to 2 weeks after the final treatment cycle or after the last study drug administration, if the treatment period was prematurely terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Diagnosis of refractory or relapsed ALL or AML.
- 12 months to 21 years of age at the time of informed consent.
- Weight ≥10 kg
- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from the toxic side effects of such therapy. In the instance of rapidly progressive disease, anti-leukemia therapy may be administered within the 2-week period as long as the subject has recovered from the toxic effects of that therapy. Also, intrathecal therapy may be administered within the 2-week period for subjects with CNS disease.
- No stem cell transplant regimen within 3 months prior to first dose of study drug.
Key exclusion criteria (7 listed)
- Concomitant therapy that includes other chemotherapy that is or may be active against ALL or AML, except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents. Concurrent radiation therapy and immunosuppressive therapy are not allowed. Concurrent intrathecal therapy per standard of care is allowed for subjects with CNS disease.
- Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (≤6 months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements. Cardiac patients with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded.
- Active graft-versus-host disease (GVHD).
- Pregnant, lactating, or not using adequate contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal Annamycin3-day IV infusion | Drug | – |
Primary outcome
To evaluate the safety and identify the MTD of liposomal annamycin and to evaluate the antileukemic activity of liposomal annamycin in children and young adults.
Time frame: 8 months
1 secondary outcome
To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Participants are no longer being examined or treated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Jacob, Ph.D. study director
Callisto Pharmaceuticals, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal Annamycin in people with Acute Lymphocytic Leukemia and Acute Myelogenous Leukemia, run by Callisto Pharmaceuticals at 3 sites 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 15 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Participants are no longer being examined or treated.). Results are not available in the source record.
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?
To evaluate the safety and identify the MTD of liposomal annamycin and to evaluate the antileukemic activity of liposomal annamycin in children and young adults. (time frame: 8 months). It is what the study was designed to measure, not a finding.
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 31 Aug 2011.