Solid TumorsPhase 1NCT00511017
Doxercalciferol in Recurrent Pediatric Solid Tumors
A Phase 1 study testing Doxercalciferol in people with Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The safety of this drug will also be studied. Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D. Read more about this study
- Who is it for?
- Ages 2 to 26 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Doxercalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2010
- 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 2 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written and voluntary consent obtained from the patient or their legal guardians.
- Patient must be greater than 2 and less than 26 years old at time of study entry or at time of initial diagnosis
- Patient must have had histologic verification of a solid malignancy at initial diagnosis (excluding brain stem tumors and visual pathway gliomas)
- Patient must have recurrent measurable or evaluable disease after therapy or refractory to conventional therapy with presence of disease confirmed by standard imaging or biopsy
- Must start protocol therapy within two weeks of disease evaluation and determination of eligibility.
- Performance status of >20% on Lansky play scale for subjects <10 years of age, >20% on Karnofsky score for subjects >= 10 years of age
Show all 13Show fewer
- Patient must have fully recovered to less than or equal to grade 1 from the acute toxic effects of prior therapy, to meet eligibility criteria
- Adequate bone marrow function defined as peripheral absolute neutrophil count (ANC) equal or more than 500/mm^3, Hemoglobin equal or more than 8g/dl, Platelets equal or more than 20,000/mm^3
- Adequate renal function defined as serum creatinine <1.5 X upper limit of normal (ULN) or age adjusted creatinine clearance of >70ml/min/1.73m^2
- Adequate liver function defined as total bilirubin <1.5 X upper limit of normal (ULN) and AST <2 X upper limit of normal (ULN)
- Serum calcium, phosphorus, or PTH levels must be </= to the upper limit of normal age adjusted values per institutional guidelines.
- Urine calcium level must be </= to the upper limit of normal value per institutional guidelines
- Women of childbearing potential must have a negative serum or urine pregnancy test and not be breastfeeding prior to study therapy. Women of childbearing potential must be using an adequate form of contraception to avoid pregnancy during therapy and for at least 4 weeks after the end of study therapy in such a manner that the risk of pregnancy is minimized (Women of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization)
Who cannot join
- Any past history of urine calcium stones, idiopathic hypercalcemia, hereditary bone disease, or hypercalciuria in the subject
- Concurrent Medications: Patients currently taking digitalis or thiazides are ineligible
- Concurrent Medications: Oral calcium and vitamin D supplements and all homeopathic medications must be discontinued 2 weeks prior to study entry and while on study therapy.
- Use of other anti-tumor therapy, including but not limited to chemotherapy, radiation therapy, immunotherapy, other investigational agents or other biologic therapy, during study therapy, with the exception of palliative radiation therapy to non-index lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Doxercalciferol in Recurrent Pediatric Solid Tumors
The goal of this clinical research study is to find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The safety of this drug will also be studied. Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D.
Read the detailed description
The Study Drug:
Doxercalciferol is designed to "copy the actions" of Vitamin D without causing blood levels of calcium to be too high.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will begin receiving doxercalciferol. The dose you will receive will be based on how many participants have been enrolled before you, and on the safety data that is available. You will remain on the same dose level throughout this study. There will be up to 9 participants enrolled in each group of the same dose. The first group of participants enrolled on this study will be given small doses of doxercalciferol. If no intolerable side effects are experienced, the next group of participants will be enrolled at a higher dose level. This process will continue until researchers find the highest tolerable dose of doxercalciferol, among the 5 dose levels being tested, that can be given without intolerable side effects occurring.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin the first "cycle" of the study drug. Each cycle of chemotherapy will last 28 days.
Doxercalciferol will be taken by mouth every day for 28 days.
Study Visits:
Every week during Cycle 1, you will have a physical exam, and urine will be collected for routine tests.
Two (2) times every week while you are on study, blood (about 2 teaspoons) will be drawn for routine tests.
During Cycles 2 and beyond, you will have the following tests and procedures performed:
- Urine will be collected for routine tests.
- ECG and ECHO will be repeated again only if your doctor feels it is necessary.
- You may also have a computed tomography (CT) scan and/or magnetic resonance imaging (MRI) to check the status of the disease.
Length of Study:
You may remain on this study for up to 12 cycles.You will be taken off this study if the disease gets worse or intolerable side effects occur. The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest or if you do not follow the study rules.
You can stop participating in this study at any time. Tell the study doctor if you are thinking about leaving the study so that any risks can be reviewed by your study doctor and so that follow-up care and testing can be discussed. The study doctor will tell you how to stop safely.
End-of-Study Visit:
Once you are off-study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed.
- You will have a physical exam.
- Blood (around 2 teaspoons) and urine will be collected for routine tests.
- You may also have a CT scan and/or MRI to check the status of the disease.
Long-Term Follow-Up:
After the end-of-study visit, you will have a study visit every month for the first year and then once a year for 10 years. At these visits, you will have a physical exam.
You may also have CT scans and/or MRIs every 8 weeks for the 1st 6 months, every 3 months for the next year, then every 6 months for 1 1/2 years, and then at least 1 time a year after that. This will be done to check the status of your disease.
Researchers would like to keep track of your medical condition and some general health information about you through yearly follow-up visits, letters, and/or phone contact, for up to 10 years. More information (such as other treatments and/or disease response) will be collected if follow-up studies show changes in the disease or in your overall health.
If the disease has gotten worse, researchers will keep track of which parts of your body are involved. Researchers will also collect information about any other cancers or major organ problems you might have developed. Keeping in touch with you and checking on your condition will help researchers look at the long-term effects of the study.
This is an investigational study. Doxercalciferol is FDA approved and commercially available for reducing high levels of a hormone in patients undergoing chronic renal dialysis. Its use in this study, for this disease, is investigational.
Up to 24 patients will take part in the study. All will be enrolled at M. D. Anderson.
- Conditions
- Solid Tumors
- Being tested
- Doxercalciferol
- Keywords
- Solid Tumors, Doxercalciferol, Pediatric Cancer, Recurrent Pediatric Solid Tumors, Calcium, Vitamin D
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxercalciferolDrug
.05 mcg/kg by mouth daily x 28 Days
| Study group | Role | What they receive |
|---|---|---|
| Doxercalciferol | Experimental | Not described Receives: Drug: Doxercalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: Continual reassessment method during 28 day cycles, weekly visits for first cycle and monthly for each additional cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Slow accrual.
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 M.D. Anderson Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter E. Zage, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511017
- Sponsor's protocol ID
- 2006-0423
- Status last verified
- Jul 2012
- First submitted
- 2 Aug 2007
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Doxercalciferol in Recurrent Pediatric Solid Tumors
- ClinicalTrials.gov ID
- NCT00511017
- Acronym / sponsor ID
- 2006-0423
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, Doxercalciferol, Pediatric Cancer, Recurrent Pediatric Solid Tumors, Calcium, Vitamin D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Aug 2007 (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.
The goal of this clinical research study is to find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The safety of this drug will also be studied. Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D.
Detailed description
The Study Drug:
Doxercalciferol is designed to "copy the actions" of Vitamin D without causing blood levels of calcium to be too high.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will begin receiving doxercalciferol. The dose you will receive will be based on how many participants have been enrolled before you, and on the safety data that is available. You will remain on the same dose level throughout this study. There will be up to 9 participants enrolled in each group of the same dose. The first group of participants enrolled on this study will be given small doses of doxercalciferol. If no intolerable side effects are experienced, the next group of participants will be enrolled at a higher dose level. This process will continue until researchers find the highest tolerable dose of doxercalciferol, among the 5 dose levels being tested, that can be given without intolerable side effects occurring.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin the first "cycle" of the study drug. Each cycle of chemotherapy will last 28 days.
Doxercalciferol will be taken by mouth every day for 28 days.
Study Visits:
Every week during Cycle 1, you will have a physical exam, and urine will be collected for routine tests.
Two (2) times every week while you are on study, blood (about 2 teaspoons) will be drawn for routine tests.
During Cycles 2 and beyond, you will have the following tests and procedures performed:
- Urine will be collected for routine tests.
- ECG and ECHO will be repeated again only if your doctor feels it is necessary.
- You may also have a computed tomography (CT) scan and/or magnetic resonance imaging (MRI) to check the status of the disease.
Length of Study:
You may remain on this study for up to 12 cycles.You will be taken off this study if the disease gets worse or intolerable side effects occur. The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest or if you do not follow the study rules.
You can stop participating in this study at any time. Tell the study doctor if you are thinking about leaving the study so that any risks can be reviewed by your study doctor and so that follow-up care and testing can be discussed. The study doctor will tell you how to stop safely.
End-of-Study Visit:
Once you are off-study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed.
- You will have a physical exam.
- Blood (around 2 teaspoons) and urine will be collected for routine tests.
- You may also have a CT scan and/or MRI to check the status of the disease.
Long-Term Follow-Up:
After the end-of-study visit, you will have a study visit every month for the first year and then once a year for 10 years. At these visits, you will have a physical exam.
You may also have CT scans and/or MRIs every 8 weeks for the 1st 6 months, every 3 months for the next year, then every 6 months for 1 1/2 years, and then at least 1 time a year after that. This will be done to check the status of your disease.
Researchers would like to keep track of your medical condition and some general health information about you through yearly follow-up visits, letters, and/or phone contact, for up to 10 years. More information (such as other treatments and/or disease response) will be collected if follow-up studies show changes in the disease or in your overall health.
If the disease has gotten worse, researchers will keep track of which parts of your body are involved. Researchers will also collect information about any other cancers or major organ problems you might have developed. Keeping in touch with you and checking on your condition will help researchers look at the long-term effects of the study.
This is an investigational study. Doxercalciferol is FDA approved and commercially available for reducing high levels of a hormone in patients undergoing chronic renal dialysis. Its use in this study, for this disease, is investigational.
Up to 24 patients will take part in the study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxercalciferol | Experimental | Drug: Doxercalciferol |
Who may qualify
- Ages
- 2 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Written and voluntary consent obtained from the patient or their legal guardians.
- Patient must be greater than 2 and less than 26 years old at time of study entry or at time of initial diagnosis
- Patient must have had histologic verification of a solid malignancy at initial diagnosis (excluding brain stem tumors and visual pathway gliomas)
- Patient must have recurrent measurable or evaluable disease after therapy or refractory to conventional therapy with presence of disease confirmed by standard imaging or biopsy
- Must start protocol therapy within two weeks of disease evaluation and determination of eligibility.
Key exclusion criteria (4 listed)
- Any past history of urine calcium stones, idiopathic hypercalcemia, hereditary bone disease, or hypercalciuria in the subject
- Concurrent Medications: Patients currently taking digitalis or thiazides are ineligible
- Concurrent Medications: Oral calcium and vitamin D supplements and all homeopathic medications must be discontinued 2 weeks prior to study entry and while on study therapy.
- Use of other anti-tumor therapy, including but not limited to chemotherapy, radiation therapy, immunotherapy, other investigational agents or other biologic therapy, during study therapy, with the exception of palliative radiation therapy to non-index lesions.
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 |
|---|---|---|
| Doxercalciferol.05 mcg/kg by mouth daily x 28 Days | Drug | Doxercalciferol |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Continual reassessment method during 28 day cycles, weekly visits for first cycle and monthly for each additional cycle
Results and safety
The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Solid Tumors
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
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.
Peter E. Zage, MD, PhD principal investigator
M.D. Anderson Cancer Center
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 Doxercalciferol in people with Solid Tumors, run by M.D. Anderson Cancer Center 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 13 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Jul 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 was stopped early (reason given: Slow accrual.). Results are not available in the source record.
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?
Maximum Tolerated Dose (MTD) (time frame: Continual reassessment method during 28 day cycles, weekly visits for first cycle and monthly for each additional cycle). 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 31 Jul 2012.