Solid TumorsPhase 1NCT00125840
Clofarabine in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing clofarabine (IV formulation) in people with Solid Tumors and Leukemia, Lymphocytic, Acute, Pediatric, run by Genzyme, a Sanofi Company at 2 sites in United States.
Trial summary
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Leukemia, Lymphocytic, Acute, Pediatric, Leukemia, Lymphocytic, Acute, Adult
- What is being tested?
- clofarabine (IV formulation)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Aug 2002to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a pathologic diagnosis of advanced solid tumors
- After MTD is established, patients must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Be greater than or equal to 18 years old
- Not eligible for therapy of higher curative potential
- Have a Karnofsky Performance Status (KPS) greater than or equal to 70
- Have an estimated life expectancy of greater than or equal to 12 weeks
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- Have a negative serum or urine pregnancy test within 7 days of study enrollment (if patient is a female of childbearing potential)
- Male and female patients who are fertile must agree to use an effective barrier method of birth control (latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy
- Sign a written informed consent form
- Able to comply with study procedures and follow-up examinations
- Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: ANC: greater than or equal to 1.5 × 10 9th/L; Platelets: greater than or equal to 100 × 10 9th/L; Serum bilirubin: less than 2.0 mg/dL; AST and ALT: less than 3 x ULN (Institutional Upper Limit of Normal) without liver involvement OR less than 5 x ULN(*) with liver involvement; Serum creatinine: less than 2.0 mg/dL; Echocardiogram shortening fraction: greater than or equal to 28%(Not on pharmacologic support); or Ejection fraction greater than or equal to 50% (Not on pharmacologic support).
Who cannot join
- Received previous treatment with clofarabine.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Prior malignancy with less than a 2-year disease-free interval, except for adequately treated basal cell or squamous cell skin cancer; or in situ cancer of the cervix.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have received any chemotherapy, major surgery, or irradiation, whether conventional or investigational, < 4 weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea) and/or have not recovered from acute toxicities of all previous therapy prior to enrollment.
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- Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study (eg, uncontrolled severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, etc.).
- Have received prior radiation therapy to greater than or equal to 25% of the bone marrow (eg, no whole pelvic irradiation is allowed) and have not recovered from the acute side effects of radiotherapy.
- Have received prior radiation therapy to the mediastinal region.
- Have a broncho-alveolar pattern evident on chest x-ray.
- Have symptomatic or untreated central nervous system (CNS) metastases.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mary Crowley Medical Research Center
Dallas, Texas, 75246
US Oncology Tyler Cancer Center
Tyler, Texas, 75702
About this study
Official title: A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions:
- What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days?
- What are the side effects of clofarabine when given on this schedule?
- How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle.
- Will clofarabine help treat a specific cancer?
- Conditions
- Solid Tumors, Leukemia, Lymphocytic, Acute, Pediatric, Leukemia, Lymphocytic, Acute, Adult, Leukemia, Myelocytic, Acute, Pediatric, Leukemia, Myelocytic, Acute, Adult, Myelodysplastic Syndromes, Adult
- Being tested
- clofarabine (IV formulation)
- Keywords
- CLO151, Clolar, Pediatric ALL and AML, Adult ALL and AML and MDS
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, 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.
clofarabine (IV formulation)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD)/recommended phase II dose (RP2D) is the dose at which less than or equal to 1 of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startAug 2002
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125840
- Sponsor's protocol ID
- CLO151
- Status last verified
- Feb 2014
- First submitted
- 29 Jul 2005
- Last updated
- 5 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00125840
- Acronym / sponsor ID
- CLO151
- Conditions
- Solid Tumors, Leukemia, Lymphocytic, Acute, Pediatric, Leukemia, Lymphocytic, Acute, Adult, Leukemia, Myelocytic, Acute, Pediatric, Leukemia, Myelocytic, Acute, Adult, Myelodysplastic Syndromes, Adult
- Keywords
- CLO151, Clolar, Pediatric ALL and AML, Adult ALL and AML and MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Aug 2007 (actual)
- First posted
- 2 Aug 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.
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions:
- What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days?
- What are the side effects of clofarabine when given on this schedule?
- How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle.
- Will clofarabine help treat a specific cancer?
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a pathologic diagnosis of advanced solid tumors
- After MTD is established, patients must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Be greater than or equal to 18 years old
- Not eligible for therapy of higher curative potential
- Have a Karnofsky Performance Status (KPS) greater than or equal to 70
Key exclusion criteria (11 listed)
- Received previous treatment with clofarabine.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Prior malignancy with less than a 2-year disease-free interval, except for adequately treated basal cell or squamous cell skin cancer; or in situ cancer of the cervix.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
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 |
|---|---|---|
| clofarabine (IV formulation) | Drug | – |
Primary outcome
The maximum tolerated dose (MTD)/recommended phase II dose (RP2D) is the dose at which less than or equal to 1 of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- US FDA Approved Full Prescribing Information for Clolar®Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 clofarabine (IV formulation) in people with Solid Tumors and Leukemia, Lymphocytic, Acute, Pediatric, run by Genzyme, a Sanofi Company at 2 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 11 inclusion and 11 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 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
The maximum tolerated dose (MTD)/recommended phase II dose (RP2D) is the dose at which less than or equal to 1 of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.. 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 5 Feb 2014.