Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00098514
Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors
A Phase 1 study testing talotrexin ammonium in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- talotrexin ammonium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to May 2011
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of malignant solid tumor
- Metastatic or inoperable disease
- No known curative or survival-prolonging palliative therapy exists OR failed these prior therapies
- No leukemia
- No primary CNS tumor
- No third-space fluid collection (i.e., pleural effusion, ascites)
- Clinically insignificant small pleural or peritoneal effusions identified by CT scan, MRI, or other diagnostic test allowed
- No active* brain metastases, including the following:
- Evidence of cerebral edema by CT scan or MRI
- Progression since prior imaging study
- Requirement for steroids
- Clinical symptoms of/from brain metastases NOTE: *Treated and/or stable brain metastasis allowed provided patient is asymptomatic
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 2 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- RBC folate ≥ lower limit of normal
Hepatic
- Bilirubin normal
- SGOT and SGPT ≤ 2.5 times upper limit of normal
Renal
- Creatinine clearance ≥ 50 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other uncontrolled serious medical or psychiatric illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior bone marrow transplantation
Chemotherapy
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- More than 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- At least 3 weeks since prior surgery
Other
- Recovered from prior therapy
- More than 3 weeks since prior antifolate therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Study Of PT523 In Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors.
- Determine the safety of this drug in these patients.
- Determine the dose-limiting toxic effects of this drug in these patients.
Secondary
- Determine the pharmacokinetics of this drug in these patients.
- Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients.
- Determine, preliminarily, the antitumor efficacy of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of talotrexin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.
- Being tested
- talotrexin ammonium
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talotrexin ammoniumDrug
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1a | Experimental | 10 mg/m2 dose of PT523 administered day 1 of a 28-day cycle as a 5 minute IV infusion (IV bolus) Receives: Drug: talotrexin ammonium |
| Dose Level 1b | Experimental | 5 mg/m2 dose of PT523 administered days 1 and 8 of a 28-day cycle as a 5 minute IV infusion Receives: Drug: talotrexin ammonium |
| Dose Level 1c | Experimental | 3.33 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion Receives: Drug: talotrexin ammonium |
| Dose Level 2 | Experimental | 5 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion Receives: Drug: talotrexin ammonium |
| Dose Level 3 | Experimental | 7.5 mg/m2 dose (or 6.7 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion Receives: Drug: talotrexin ammonium |
| Dose Level 4 | Experimental | 11.25 mg/m2 dose (or 9 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion Receives: Drug: talotrexin ammonium |
| Dose Level 5 | Experimental | 17 mg/m2 dose (or 12 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion Receives: Drug: talotrexin ammonium |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2004 (estimated)
- Study startDec 2003
- Primary completionMar 2007
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Model description
- There were 7 potential PT523 single agent dose levels to be evaluated in this phase I study
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Joseph Paul Eder, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098514
- Sponsor's protocol ID
- 03-183
- Other IDs
- P30CA006516, CDR0000400150, NCI-6400, DFCI-IRB-03183, HANABIO-DFCI-02000
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2004
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of PT523 In Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00098514
- Acronym / sponsor ID
- 03-183
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003 (actual)
- Primary completion
- Mar 2007 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Dec 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.
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors.
- Determine the safety of this drug in these patients.
- Determine the dose-limiting toxic effects of this drug in these patients.
Secondary
- Determine the pharmacokinetics of this drug in these patients.
- Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients.
- Determine, preliminarily, the antitumor efficacy of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of talotrexin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- There were 7 potential PT523 single agent dose levels to be evaluated in this phase I study
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1a | Experimental | Drug: talotrexin ammonium10 mg/m2 dose of PT523 administered day 1 of a 28-day cycle as a 5 minute IV infusion (IV bolus) |
| Dose Level 1b | Experimental | Drug: talotrexin ammonium5 mg/m2 dose of PT523 administered days 1 and 8 of a 28-day cycle as a 5 minute IV infusion |
| Dose Level 1c | Experimental | Drug: talotrexin ammonium3.33 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion |
| Dose Level 2 | Experimental | Drug: talotrexin ammonium5 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion |
| Dose Level 3 | Experimental | Drug: talotrexin ammonium7.5 mg/m2 dose (or 6.7 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion |
| Dose Level 4 | Experimental | Drug: talotrexin ammonium11.25 mg/m2 dose (or 9 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion |
| Dose Level 5 | Experimental | Drug: talotrexin ammonium17 mg/m2 dose (or 12 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| talotrexin ammonium | Drug | Dose Level 1a, Dose Level 1b, Dose Level 1c, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5 |
Primary outcome
Not reported in the source record.
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 18 Dec 2017.
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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.
Joseph Paul Eder, MD principal investigator
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 talotrexin ammonium in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Dana-Farber Cancer Institute 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: finished, as of the sponsor's last update on 18 Dec 2017. 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 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.
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 18 Dec 2017.