Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00547547
High-Selenium Brassica Juncea, Irinotecan, and Capecitabine in Treating Patients With Advanced Cancer
A Phase 1 study testing high-selenium Brassica juncea, capecitabine and irinotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Brassica juncea that contains high amounts of selenium may slow the growth of cancer cells. Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- high-selenium Brassica juncea, capecitabine and irinotecan hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Aug 2012
- 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
- Patients with advanced, biopsy-proven cancer for which there is no standard curative therapy
- Karnofsky Performance status >= 60
- Prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
- Prior capecitabine and/or irinotecan are allowed if subject did not progress while on treatment or within 6 months of treatment with these medications either alone or in combination
- Prior radiation therapy allowed if < 30% of marrow treated
- Alanine aminotransferase (ALT) and alkaline phosphatase with 3x upper limit of normal
Show all 13Show fewer
- Serum bilirubin within normal limits
- Absolute neutrophil count >= 15000/ul
- Platelet count >= 100,000/ul
- Hemoglobin >= 10 gm/dl - transfusion allowed to achieve this
- Serum creatinine within 1.5 x upper limit of normal
- Ability to understand and sign an IRB approved informed consent
- Ability to use appropriate contraception and no evidence of pregnancy in female patients of reproductive potential
Who cannot join
- No significant medical or psychiatric condition that would make treatment unsafe
- No active brain metastases (patients who have treated brain metastases and are stable off of steroids are eligible)
- Nursing women
- Patients must be able to comply with protocol related studies and follow-up
- Patients who are UGT1a1 7/7 positive will be excluded from the dose escalation portion of the trial, but may participate in the cohort of patients treated at the MTD
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010-3000
South Pasadena Cancer Center
Pasadena, California, 91105
About this study
Official title: A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine
RATIONALE: Brassica juncea that contains high amounts of selenium may slow the growth of cancer cells. Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-selenium Brassica juncea together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of high-selenium Brassica juncea and capecitabine when given together with irinotecan in treating patients with advanced cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of high-selenium Brassica juncea (BJ-Se) and capecitabine when administered in combination with irinotecan hydrochloride in patients with advanced malignancies.
- To determine the effects of BJ-Se on the pharmacokinetics of irinotecan hydrochloride and capecitabine.
Secondary
- To determine the effect of BJ-Se on the serum selenium and protein profile.
- To correlate response and tolerance to this regimen with expression of key enzymes involved as targets or with the metabolism of the components of treatment, including thymidylate synthase and dihydropyrimidine dehydrogenase.
- To evaluate changes to potential selenium related parameters.
OUTLINE: This is a multicenter, dose-escalation study of high-selenium Brassica juncea (BJ-Se) and capecitabine. The dose of capecitabine is escalated first, followed by dose escalation of BJ-Se.
Patients receive oral BJ-Se on days -7 to 21 in course 1 and on days 1-21 in all other courses. Patients also receive irinotecan IV on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
After the maximum tolerated dose (MTD) of capecitabine and BJ-Se are determined, additional patients are accrued and receive treatment at the MTD. Blood is collected from these patients during course 1 for pharmacokinetic studies.
- Being tested
- high-selenium Brassica juncea, capecitabine, irinotecan hydrochloride
- 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.
high-selenium Brassica junceaDietary supplement
Dose Level A: 3200 mcg orally day -7 through duration of treatment. Dose Level B: 4800 mcg orally day -7 through duration of treatment. Dose Level C: 6400 mcg orally day -7 through duration of treatment. Dose Level D: 7200 mcg orally day -7 through duration of treatment. Dose Level E: 8000 mcg orally day -7 through duration of treatment.
capecitabineDrug
Dose Level 1: 750 mg/m2, 2x daily x 14 days every 21 days. Dose Level 1.5: 850 mg/m2, 2x daily x 14 days every 21 days. Dose Level 2: 1000 mg/m2, 2x daily x 14 days every 21 days.
Dose Level 1: 100 mg/m2 on day 1 and day 8 every 21 days. Dose Level -1: 75 mg/m2 on day 1 and day 8 every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (high-selenium therapy and chemotherapy) | Experimental | Not described Receives: Dietary Supplement: high-selenium Brassica juncea; Drug: capecitabine; Drug: irinotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine
Measured: After two 21 day cycles of treatment
Toxicity
Measured: After two 21 day cycles of treatment
Pharmacokinetics
Measured: For patients treated at the MTD only at the end of cycle one of treatment
Secondary outcomes (1)
Serum selenium and protein profile
Measured: 21 days after the start of the last cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startApr 2006
- Primary completionAug 2012
- Study completionAug 2012
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 City of Hope Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yun I. Yen, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547547
- Sponsor's protocol ID
- 05122
- Other IDs
- P30CA033572, CHNMC-05122, CDR0000570284
- Status last verified
- Nov 2015
- First submitted
- 19 Oct 2007
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine
- ClinicalTrials.gov ID
- NCT00547547
- Acronym / sponsor ID
- 05122
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Oct 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.
RATIONALE: Brassica juncea that contains high amounts of selenium may slow the growth of cancer cells. Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-selenium Brassica juncea together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of high-selenium Brassica juncea and capecitabine when given together with irinotecan in treating patients with advanced cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of high-selenium Brassica juncea (BJ-Se) and capecitabine when administered in combination with irinotecan hydrochloride in patients with advanced malignancies.
- To determine the effects of BJ-Se on the pharmacokinetics of irinotecan hydrochloride and capecitabine.
Secondary
- To determine the effect of BJ-Se on the serum selenium and protein profile.
- To correlate response and tolerance to this regimen with expression of key enzymes involved as targets or with the metabolism of the components of treatment, including thymidylate synthase and dihydropyrimidine dehydrogenase.
- To evaluate changes to potential selenium related parameters.
OUTLINE: This is a multicenter, dose-escalation study of high-selenium Brassica juncea (BJ-Se) and capecitabine. The dose of capecitabine is escalated first, followed by dose escalation of BJ-Se.
Patients receive oral BJ-Se on days -7 to 21 in course 1 and on days 1-21 in all other courses. Patients also receive irinotecan IV on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
After the maximum tolerated dose (MTD) of capecitabine and BJ-Se are determined, additional patients are accrued and receive treatment at the MTD. Blood is collected from these patients during course 1 for pharmacokinetic studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (high-selenium therapy and chemotherapy) | Experimental | Dietary Supplement: high-selenium Brassica juncea, Drug: capecitabine, Drug: irinotecan hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with advanced, biopsy-proven cancer for which there is no standard curative therapy
- Karnofsky Performance status >= 60
- Prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
- Prior capecitabine and/or irinotecan are allowed if subject did not progress while on treatment or within 6 months of treatment with these medications either alone or in combination
- Prior radiation therapy allowed if < 30% of marrow treated
Key exclusion criteria (5 listed)
- No significant medical or psychiatric condition that would make treatment unsafe
- No active brain metastases (patients who have treated brain metastases and are stable off of steroids are eligible)
- Nursing women
- Patients must be able to comply with protocol related studies and follow-up
- Patients who are UGT1a1 7/7 positive will be excluded from the dose escalation portion of the trial, but may participate in the cohort of patients treated at the MTD
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 |
|---|---|---|
| high-selenium Brassica junceaDose Level A: 3200 mcg orally day -7 through duration of treatment. Dose Level B: 4800 mcg orally day -7 through duration of treatment. Dose Level C: 6400 mcg orally day -7 through duration of treatment. Dose Level D: 7200 mcg orally day -7 through duration of treatment. Dose Level E: 8000 mcg orally day -7 through duration of treatment. | Dietary supplement | Treatment (high-selenium therapy and chemotherapy) |
| capecitabineDose Level 1: 750 mg/m2, 2x daily x 14 days every 21 days. Dose Level 1.5: 850 mg/m2, 2x daily x 14 days every 21 days. Dose Level 2: 1000 mg/m2, 2x daily x 14 days every 21 days. | Drug | Treatment (high-selenium therapy and chemotherapy) |
| irinotecan hydrochlorideDose Level 1: 100 mg/m2 on day 1 and day 8 every 21 days. Dose Level -1: 75 mg/m2 on day 1 and day 8 every 21 days. | Drug | Treatment (high-selenium therapy and chemotherapy) |
Primary outcome
Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine
Time frame: After two 21 day cycles of treatment
Toxicity
Time frame: After two 21 day cycles of treatment
Pharmacokinetics
Time frame: For patients treated at the MTD only at the end of cycle one of treatment
1 secondary outcome
Serum selenium and protein profile
Time frame: 21 days after the start of the last cycle of treatment
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 6 Nov 2015.
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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.
Yun I. Yen, MD principal investigator
City of Hope Medical Center
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 high-selenium Brassica juncea, capecitabine and irinotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center 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 13 inclusion and 5 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 6 Nov 2015. 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?
Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine (time frame: After two 21 day cycles of treatment). The study lists 3 primary outcomes in all. 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 6 Nov 2015.