Acute Lymphocytic LeukemiaPhase 1/2NCT00271063
Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
A Phase 1/2 study testing Liposomal Annamycin in people with Acute Lymphocytic Leukemia, run by Callisto Pharmaceuticals at 3 sites in United States.
Trial summary
This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia
- What is being tested?
- Liposomal Annamycin
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to Apr 2008
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)
- Age greater than or equal to 15 years
- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
- No investigational therapy within 4 weeks of first dose of study drug
- ECOG performance status (PS) 0 to 2.
- Adequate liver function
- Adequate renal function
- Signed informed consent
Who cannot join
- Concommitant therapy that includes other chemotherapy that is or may be active against ALL (except central nervous system [CNS] therapy)
- Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Cardiac ejection fraction less than 40%
- Clinically relevant serious co-morbid medical conditions.
- Pregnant, lactating or not using adequate contraception.
- Known allergy to doxorubicin or anthracyclines.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Barbara Anderson, RN, 716-845-8360
Meir Wetzler, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Michelle Thomas, RN, BSN, OCN, 713-763-8776
Hagop Kantarjian, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Dominique Pinard, MS, 718-920-2090
Samir Parekh, MD
About this study
Official title: Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.
Read the detailed description
This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal annamycin are planned: 190, 230, 280, and 310 mg/m2/day.
- Conditions
- Acute Lymphocytic Leukemia
- Being tested
- Liposomal Annamycin
- Keywords
- Refractory or Relapsed Acute Lymphocytic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 tolerability of L-Annamycin
Measured: 8 months
MTD
Measured: 8 months
Secondary outcomes (2)
To study multi drug-resistant (MDR)-1 encoded P-170 glycoprotein expression and MDR-1 multidrug-resistant-associated protein (MRP), lung-resistance associated protein LRP), and breast cancer resistance protein (BCRP) mRNA levels
Measured: 8 months
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 posted30 Dec 2005 (estimated)
- Study startOct 2005
- Study completionApr 2008 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Callisto Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Jacob, PhD, Study director, Callisto Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271063
- Sponsor's protocol ID
- CP-103
- Status last verified
- Dec 2007
- First submitted
- 29 Dec 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00271063
- Acronym / sponsor ID
- CP-103
- Conditions
- Acute Lymphocytic Leukemia
- Keywords
- Refractory or Relapsed Acute Lymphocytic Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Callisto PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Apr 2008 (estimated)
- First posted
- 30 Dec 2005 (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/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.
Detailed description
This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal annamycin are planned: 190, 230, 280, and 310 mg/m2/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)
- Age greater than or equal to 15 years
- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
- No investigational therapy within 4 weeks of first dose of study drug
- ECOG performance status (PS) 0 to 2.
Key exclusion criteria (6 listed)
- Concommitant therapy that includes other chemotherapy that is or may be active against ALL (except central nervous system [CNS] therapy)
- Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Cardiac ejection fraction less than 40%
- Clinically relevant serious co-morbid medical conditions.
- 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 tolerability of L-Annamycin
Time frame: 8 months
MTD
Time frame: 8 months
2 secondary outcomes
To study multi drug-resistant (MDR)-1 encoded P-170 glycoprotein expression and MDR-1 multidrug-resistant-associated protein (MRP), lung-resistance associated protein LRP), and breast cancer resistance protein (BCRP) mRNA levels
Time frame: 8 months
To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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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, PhD study director
Callisto Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Liposomal Annamycin in people with Acute Lymphocytic 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Dec 2007. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig C. Talluto, PhD, abd (212-297-0010 ext. 231, ctalluto@callistopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of L-Annamycin (time frame: 8 months). 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?
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 21 Dec 2007.