Kidney CancerPhase 2NCT00365768
Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
A Phase 2 study testing Glutamine in people with Kidney Cancer and Leukemia, run by Columbia University at 1 site in United States.
Trial summary
RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Kidney Cancer, Leukemia, Lymphoma
- What is being tested?
- Glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the age of 5 and 21 years old.
- Patients who demonstrate the ability to complete the assessment instruments at baseline.
- Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.
Who cannot join
- Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
- Patients with recurrent disease.
- Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
- Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
- Patients with hepatic encephalopathy or hyperammonemia.
- Patients with a focally abnormal neurologic exam.
Trial locations and contacts
1 site in 1 country.
United States1 site
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine.
PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the incidence of vincristine-induced peripheral neuropathy in pediatric patients with lymphoma, leukemia, or solid tumors.
Secondary
- Compare the safety of glutamine vs placebo in these patients.
- Compare the efficacy of glutamine vs placebo in reducing the progression and/or resolution of vincristine-induced peripheral neuropathy in these patients.
- Compare the effect of glutamine supplementation vs placebo on chemotherapy-related toxicities in these patients.
- Compare the effect of glutamine vs placebo on measures of quality of life in these patients.
- Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor and glutamine levels in these patients.
- Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.
OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
- Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Patients in both arms undergo neuropsychological and clinical neurological assessment, blood collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and quality of life assessment on days 1, 21, and 42.
After completion of study treatment, patients are followed for an additional 21 days.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
- Conditions
- Kidney Cancer, Leukemia, Lymphoma, Neurotoxicity, Peripheral Neuropathy, Sarcoma
- Being tested
- Glutamine, Placebo
- Keywords
- stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage II childhood small noncleaved cell lymphoma, stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, childhood grade III lymphomatoid granulomatosis, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, stage I childhood large cell lymphoma, stage I childhood lymphoblastic lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood large cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma, stage IV childhood lymphoblastic lymphoma, stage IV childhood small noncleaved cell lymphoma, childhood Burkitt lymphoma
- Medical subject headings
- Kidney Neoplasms, Leukemia, Lymphoma, Neurotoxicity Syndromes, Peripheral Nervous System Diseases, Sarcoma, Burkitt Lymphoma, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
Also called Nutritional Supplement
Administered orally twice daily for 21 days
PlaceboOther
Administered orally twice daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Glutamine | Experimental | Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. Receives: Drug: Glutamine |
| Arm II: Placebo | Placebo comparator | Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Vincristine-induced Peripheral Neuropathy
Measured: Up to 30 weeks from baseline while on Vincristine treatment
Secondary outcomes (1)
Number of Participants With Progression of Neuropathy
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startOct 2004
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Glade Bender, Columbia University
- Investigators
- Julia L. Glade-Bender, MD, Principal investigator, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365768
- Sponsor's protocol ID
- AAAA6806
- Other IDs
- CPMC-ICCR-3349
- Status last verified
- Jul 2016
- First submitted
- 16 Aug 2006
- Last updated
- 9 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
- ClinicalTrials.gov ID
- NCT00365768
- Acronym / sponsor ID
- AAAA6806
- Conditions
- Kidney Cancer, Leukemia, Lymphoma, Neurotoxicity, Peripheral Neuropathy, Sarcoma
- Keywords
- stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage II childhood small noncleaved cell lymphoma, stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Posted 9 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine.
PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the incidence of vincristine-induced peripheral neuropathy in pediatric patients with lymphoma, leukemia, or solid tumors.
Secondary
- Compare the safety of glutamine vs placebo in these patients.
- Compare the efficacy of glutamine vs placebo in reducing the progression and/or resolution of vincristine-induced peripheral neuropathy in these patients.
- Compare the effect of glutamine supplementation vs placebo on chemotherapy-related toxicities in these patients.
- Compare the effect of glutamine vs placebo on measures of quality of life in these patients.
- Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor and glutamine levels in these patients.
- Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.
OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
- Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Patients in both arms undergo neuropsychological and clinical neurological assessment, blood collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and quality of life assessment on days 1, 21, and 42.
After completion of study treatment, patients are followed for an additional 21 days.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Glutamine | Experimental | Drug: GlutamineBeginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. |
| Arm II: Placebo | Placebo comparator | Other: PlaceboBeginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients between the age of 5 and 21 years old.
- Patients who demonstrate the ability to complete the assessment instruments at baseline.
- Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.
Key exclusion criteria (6 listed)
- Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
- Patients with recurrent disease.
- Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
- Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
- Patients with hepatic encephalopathy or hyperammonemia.
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 |
|---|---|---|
| GlutamineAlso: Nutritional SupplementAdministered orally twice daily for 21 days | Drug | Arm I: Glutamine |
| PlaceboAdministered orally twice daily for 21 days | Other | Arm II: Placebo |
Primary outcome
Incidence of Vincristine-induced Peripheral Neuropathy
Time frame: Up to 30 weeks from baseline while on Vincristine treatment
1 secondary outcome
Number of Participants With Progression of Neuropathy
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Julia L. Glade-Bender, MD principal investigator
Herbert Irving Comprehensive 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 2 study testing Glutamine in people with Kidney Cancer and Leukemia, run by Columbia University 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 3 inclusion and 6 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 9 Sep 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Vincristine-induced Peripheral Neuropathy (time frame: Up to 30 weeks from baseline while on Vincristine treatment). 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 9 Sep 2016.