Recurrent Childhood Acute Lymphoblastic LeukemiaPhase 1NCT00003528
Raltitrexed in Treating Children With Refractory Acute Leukemia
A Phase 1 study testing raltitrexed in people with Recurrent Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood Acute Myeloid Leukemia, run by National Cancer Institute (NCI) at 1 site in Switzerland.
Trial summary
Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia
- What is being tested?
- raltitrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 1998to Jun 2002
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists
- No CNS leukemia
- No solid tumors
- Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)
- Life expectancy: At least 8 weeks
- Bilirubin less than 1.5 mg/dL
Show all 22Show fewer
- SGPT less than 5 times normal
- Normal creatinine for age OR GFR at least 70 mL/min
- No significant systemic illness such as infection
- No significant third space fluid collection
- Not pregnant or nursing
- Recovered from acute toxic effects of prior immunotherapy
- At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease
- At least 10 days since prior biologic therapy
- At least 1 week since prior growth factors
- At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered
- No concurrent steroids
- Recovered from acute toxic effects of all prior radiotherapy
- At least 2 weeks since prior local palliative radiotherapy (small port)
- At least 6 months since prior substantial bone marrow radiation
- No other concurrent anticancer therapy or investigational agents
- No concurrent nonsteroidal anti-inflammatory agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial of Tomudex in Children With Leukemia
Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and dose limiting toxicity of raltitrexed given for three weeks to children with refractory acute leukemia.
II. Determine the incidence and severity of other toxic effects of this regimen in these patients.
III. Determine a safe and tolerable dose of raltitrexed, administered in this manner, to be used in phase II studies.
IV. Determine the pharmacokinetics of this regimen in these patients. V. Determine if plasma 2' deoxyuridine concentrations are associated with raltitrexed toxicity or pharmacokinetics.
VI. Evaluate the antitumor activity of raltitrexed against recurrent leukemia.
OUTLINE: This is a dose escalation study.
Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity.
In the absence of dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of raltitrexed on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose.
Patients are followed every 6 months for 4 years, then annually thereafter.
- Conditions
- Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia
- Being tested
- raltitrexed
- 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.
raltitrexedDrug
Also called D1694, ICI-D1694, TDX, Tomudex
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity. Receives: Drug: raltitrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD based on incidence of DLT graded according to CTC version 2.0
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2004 (estimated)
- Study startSep 1998
- Primary completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Childhood Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven D. Weitman, Principal investigator, Swiss Pediatric Oncology Group - Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003528
- Sponsor's protocol ID
- NCI-2012-01839
- Other IDs
- 9779, U01CA097452, CDR0000066575
- Status last verified
- Jan 2013
- First submitted
- 1 Nov 1999
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Tomudex in Children With Leukemia
- ClinicalTrials.gov ID
- NCT00003528
- Acronym / sponsor ID
- NCI-2012-01839
- Conditions
- Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 1998
- Primary completion
- Jun 2002 (actual)
- First posted
- 1 Mar 2004 (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.
Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and dose limiting toxicity of raltitrexed given for three weeks to children with refractory acute leukemia.
II. Determine the incidence and severity of other toxic effects of this regimen in these patients.
III. Determine a safe and tolerable dose of raltitrexed, administered in this manner, to be used in phase II studies.
IV. Determine the pharmacokinetics of this regimen in these patients. V. Determine if plasma 2' deoxyuridine concentrations are associated with raltitrexed toxicity or pharmacokinetics.
VI. Evaluate the antitumor activity of raltitrexed against recurrent leukemia.
OUTLINE: This is a dose escalation study.
Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity.
In the absence of dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of raltitrexed on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose.
Patients are followed every 6 months for 4 years, then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: raltitrexedPatients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists
- No CNS leukemia
- No solid tumors
- Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)
- Life expectancy: At least 8 weeks
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| raltitrexedAlso: D1694, ICI-D1694, TDX, TomudexGiven IV | Drug | Arm I |
Primary outcome
MTD based on incidence of DLT graded according to CTC version 2.0
Time frame: Up to 4 weeks
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 16 Jan 2013.
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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.
Steven D. Weitman principal investigator
Swiss Pediatric Oncology Group - Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing raltitrexed in people with Recurrent Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood Acute Myeloid Leukemia, run by National Cancer Institute (NCI) at 1 site in Switzerland.
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 22 inclusion and 0 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 16 Jan 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 Switzerland. 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?
MTD based on incidence of DLT graded according to CTC version 2.0 (time frame: Up to 4 weeks). 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 16 Jan 2013.