Solid TumorsPhase 1KTN10010NCT00586560
Karenitecin in Pediatric Patients With Refractory or Recurrent Solid Tumors N10010)
A Phase 1 study testing Kareniticin and cyclophosphamide in people with Solid Tumors, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata, depending upon the presence bone marrow metastases or previous treatment with intensive myelosuppression therapy. Read more about this study
- Who is it for?
- Ages 12 months to 21 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Kareniticin and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jan 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 12 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age greater than 12 months and less than or equal to 21 years at the time of registration.
- Histological documentation of cancer (solid tumors) at initial diagnosis. The requirement for histological verification will be waived for patients with intrinsic brainstem gliomas. Patients with non-Hodgkin's lymphomas or Hodgkin's Disease are considered to have non-hematological malignancies.
- Current disease state must be one which is refractory to curative therapeutic modalities or for which there is no known curative therapy.
- Karnofsky score greater than or equal to 60 (patients over 10 years of age) and Lansky score greater than or equal to 60 (patients 10 years of age or less). Performance status scales/scores are provided in Appendix E in full protocol attached in Section S.
- Note: Neurological deficits in patients with CNS tumors must have been stable for a minimum of one week before study entry. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for performance score assessment.
- Fully recovered from any acute toxic effects of all previous chemotherapy, immunotherapy, biological therapy, or radiotherapy before study entry.
Show all 19Show fewer
- At least 90 days must have elapsed after autologous or allogeneic stem cell rescue (SCR) and the start of study treatment. There should be no evidence of active graft versus host disease.
- At least 7 days must have elapsed since the last administration of non-myelosuppressive chemotherapy, immunotherapy or biological therapy and the start of study treatment.
- At least 21 days must have elapsed since the completion of myelosuppressive chemotherapy and the start of study treatment (at least 42 days must have elapsed if treated with nitrosourea).
- At least 14 days must have elapsed since the completion of local palliative external beam radiotherapy (XRT - small port) and the start of study treatment. At least 6 months must have elapsed if prior total body irradiation (TBI), craniospinal XRT, or if radiation to 50% or more of pelvis; and at least 42 days must have elapsed if other substantial bone marrow radiation (20% or more of marrow - see Appendix F).
- Negative serum or urine pregnancy test (female patients of childbearing potential).
- Agreed to use an effective contraceptive method, including abstinence (male and female patients of reproductive potential).
- Adequate bone marrow function, defined as: • Peripheral absolute neutrophil count (ANC) 1000/mm3 or greater. • Platelet count 75,000/mm3 or greater (transfusion independent) for Stratum 1. • Platelet count 100,000/mm3 or greater (transfusion independent) for Stratum 2. • Hemoglobin 8.0 g/dL or greater (may receive red blood cell [RBC] transfusions).
- Adequate renal function; defined as: •Creatinine clearance or radioisotope glomerular filtration rate (GFR) 70 mL/min/m2 or greater.
- OR
- Serum creatinine based on age as follows: 5 years or less - 0.8 or less mg/dL over 5 years to 10 years old - 1.0 or less mg/dL over 10 years to 15 years old - 1.2 or less mg/dL over 15 years old - 1.5 or less mg/dL
- Adequate hepatic function; defined as: • Total bilirubin 1.5 mg/dL or less. • ALT 5 or less x upper limit of normal (ULN) for age. • Albumin 2 g/dL or more.
- Adequate cardiac function; defined as: • No known history of congestive heart failure. • No uncontrolled medically-important cardiac arrhythmias, including ventricular tachycardia/fibrillation, atrial fibrillation, flutter or idioventricular rhythm.
- Informed consent must be obtained before any study-specific testing is performed or administration of treatment.
Who cannot join
- Are pregnant or breastfeeding.
- Receiving, or have received growth factors that support platelet count, or white cell number or function within 7 days of screening blood work.
- Patients with CNS tumors who have not been on a stable or decreasing dose of dexamethasone for the past 7 days at the time of screening.
- Currently receiving treatment with another investigational therapy.
- Currently receiving treatment with other anti-cancer agents.
- Have CNS metastases or malignant leptomeningeal involvement that is rapidly progressive, or have poorly controlled seizures (no more than one seizure/month on anti-epileptic therapy).
- Have an active infection (including viral, fungal, bacterial, rickettsial, mycobacterial, or parasitic).
- Are judged by the Investigator to be unlikely to be able to fully comply with the study protocol and/or to complete the study or required study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Trial of Escalating Doses of Karenitecin Plus Cyclophosphamide Administered Intravenously Daily for 5 Consecutive Days in Pediatric Patients With Refractory or Recurrent Solid Tumors
This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata, depending upon the presence bone marrow metastases or previous treatment with intensive myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, as long as there is continued evidence of clinical benefit and an absence of unacceptable toxicity.
Read the detailed description
This is a Phase 1, open-label, dose-escalating study of karenitecin plus cyclophosphamide in the treatment of pediatric patients with refractory or recurrent solid tumors. All patients must have histologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no curative treatment exists.
Approximately 50 patients will be registered into the study in one of 2 strata.
Stratum 1 will include patients with known bone marrow metastases or those who have had prior intensive myelosuppression therapy. Stratum 2 will include patients without previous intensive myelosuppressive therapy or bone marrow metastases. Each stratum will accrue patients independently.
The primary endpoint in this study is the MTD and determining the recommended Phase 2 dose level for this study. The MTD will be determined for each stratum independently.
There are 3 defined periods in this study:
Period I (Screening and Registration)
Period II (Active Treatment): An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum.
Period III (End of Study): Once treatment has been discontinued, patients will undergo end-of-study procedures.
- Conditions
- Solid Tumors
- Being tested
- Kareniticin and cyclophosphamide
- Keywords
- solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kareniticin and cyclophosphamideDrug
An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle).
Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stratum 1 (~ 25 patients) will include patients with known bone marrow metastases or those who have had prior intensive myelosuppression therapy (including autologous or allogeneic stem cell rescue [SCR], total body irradiation [TBI], craniospinal irradiation [CSI], or hemipelvic radiation). Receives: Drug: Kareniticin and cyclophosphamide |
| 2 | Experimental | Stratum 2 (~ 25 patients) will include patients without previous intensive myelosuppressive therapy and bone marrow metastases. Receives: Drug: Kareniticin and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) levels and recommended Phase 2 dose levels of Karenitecin when administered intravenously for 5 consecutive days with a fixed dose of Cytoxan®
Measured: evaluation will extend at least 30 days following the last dose or until toxicities have resolved
Secondary outcomes (1)
Secondary objectives include the assessment of toxicity associated with Karenitecin administered in combination with cyclophosphamide; and the assessment of antitumor activity of Karenitecin administered in combination with cyclophosphamide.
Measured: evaluation will extend at least 30 days following the last dose or until toxicities have resolved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionJan 2011
- Study completionJan 2011
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.
- More trials run by Baylor College of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Brain Tumor Consortium
- Responsible party
- Principal investigator, Susan Blaney, Baylor College of Medicine
- Investigators
- Susan Blaney, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586560
- Sponsor's protocol ID
- H-20159
- Other IDs
- KTN10010, BMP1350
- Acronym
- KTN10010
- Status last verified
- May 2012
- First submitted
- 20 Dec 2007
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Escalating Doses of Karenitecin Plus Cyclophosphamide Administered Intravenously Daily for 5 Consecutive Days in Pediatric Patients With Refractory or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT00586560
- Acronym / sponsor ID
- KTN10010 / H-20159
- Conditions
- Solid Tumors
- Keywords
- solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Pediatric Brain Tumor Consortium
- Study start
- Feb 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Jan 2008 (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 1, open-label, single-center, dose-escalating study in pediatric patients with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata, depending upon the presence bone marrow metastases or previous treatment with intensive myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, as long as there is continued evidence of clinical benefit and an absence of unacceptable toxicity.
Detailed description
This is a Phase 1, open-label, dose-escalating study of karenitecin plus cyclophosphamide in the treatment of pediatric patients with refractory or recurrent solid tumors. All patients must have histologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no curative treatment exists.
Approximately 50 patients will be registered into the study in one of 2 strata.
Stratum 1 will include patients with known bone marrow metastases or those who have had prior intensive myelosuppression therapy. Stratum 2 will include patients without previous intensive myelosuppressive therapy or bone marrow metastases. Each stratum will accrue patients independently.
The primary endpoint in this study is the MTD and determining the recommended Phase 2 dose level for this study. The MTD will be determined for each stratum independently.
There are 3 defined periods in this study:
Period I (Screening and Registration)
Period II (Active Treatment): An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum.
Period III (End of Study): Once treatment has been discontinued, patients will undergo end-of-study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Kareniticin and cyclophosphamideStratum 1 (~ 25 patients) will include patients with known bone marrow metastases or those who have had prior intensive myelosuppression therapy (including autologous or allogeneic stem cell rescue [SCR], total body irradiation [TBI], craniospinal irradiation [CSI], or hemipelvic radiation). |
| 2 | Experimental | Drug: Kareniticin and cyclophosphamideStratum 2 (~ 25 patients) will include patients without previous intensive myelosuppressive therapy and bone marrow metastases. |
Who may qualify
- Ages
- 12 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Age greater than 12 months and less than or equal to 21 years at the time of registration.
- Histological documentation of cancer (solid tumors) at initial diagnosis. The requirement for histological verification will be waived for patients with intrinsic brainstem gliomas. Patients with non-Hodgkin's lymphomas or Hodgkin's Disease are considered to have non-hematological malignancies.
- Current disease state must be one which is refractory to curative therapeutic modalities or for which there is no known curative therapy.
- Karnofsky score greater than or equal to 60 (patients over 10 years of age) and Lansky score greater than or equal to 60 (patients 10 years of age or less). Performance status scales/scores are provided in Appendix E in full protocol attached in Section S.
- Note: Neurological deficits in patients with CNS tumors must have been stable for a minimum of one week before study entry. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for performance score assessment.
Key exclusion criteria (8 listed)
- Are pregnant or breastfeeding.
- Receiving, or have received growth factors that support platelet count, or white cell number or function within 7 days of screening blood work.
- Patients with CNS tumors who have not been on a stable or decreasing dose of dexamethasone for the past 7 days at the time of screening.
- Currently receiving treatment with another investigational therapy.
- Currently receiving treatment with other anti-cancer agents.
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 |
|---|---|---|
| Kareniticin and cyclophosphamideAn accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity. | Drug | 1, 2 |
Primary outcome
To determine the maximum tolerated dose (MTD) levels and recommended Phase 2 dose levels of Karenitecin when administered intravenously for 5 consecutive days with a fixed dose of Cytoxan®
Time frame: evaluation will extend at least 30 days following the last dose or until toxicities have resolved
1 secondary outcome
Secondary objectives include the assessment of toxicity associated with Karenitecin administered in combination with cyclophosphamide; and the assessment of antitumor activity of Karenitecin administered in combination with cyclophosphamide.
Time frame: evaluation will extend at least 30 days following the last dose or until toxicities have resolved
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 15 May 2012.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Susan Blaney, MD principal investigator
Baylor College of Medicine
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 Kareniticin and cyclophosphamide in people with Solid Tumors, run by Baylor College of Medicine 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?
The sponsor lists 19 inclusion and 8 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 15 May 2012. 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.
What does the primary outcome measure?
To determine the maximum tolerated dose (MTD) levels and recommended Phase 2 dose levels of Karenitecin when administered intravenously for 5 consecutive days with a fixed dose of Cytoxan® (time frame: evaluation will extend at least 30 days following the last dose or until toxicities have resolved). 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 15 May 2012.