Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) (TINALL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01506453
First received: January 4, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and scheduling regimens, and with varying measures of success. The hypothesis of the study is that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during treatment for ALL on the Total XVI protocol, as measured by two outcome measures: the daily dose of morphine used as needed for pain in addition to either gabapentin or placebo, as randomized, and the pain scores assessed daily.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Neuropathy
Neuropathic Pain
Drug: gabapentin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Therapeutic Interventions For Peripheral Neuropathy/Neuropathic Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) On Total XVI Protocol

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Daily total dose of oral morphine (mg/kg/day). [ Time Frame: Daily beginning day 1 for a maximum of 21 days. ] [ Designated as safety issue: No ]
    A quantity measured by pill count and/or adherence interview


Secondary Outcome Measures:
  • Pain scores right now [ Time Frame: Daily beginning day 1 through a maximum of 21 days. ] [ Designated as safety issue: No ]
    A score ranging from 0 to 10, measured by age appropriate validated pain scale

  • Pain score during the previous 24 hours [ Time Frame: Daily beginning day 1 through a maximum of 21 days ] [ Designated as safety issue: No ]
    A score ranging from 0 to 10, measured by age appropriate validated pain scale


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin
Active treatment arm.
Drug: gabapentin
Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation.
Other Name: Treatment Arm
Placebo Comparator: Placebo
Placebo arm.
Drug: placebo
Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment.
Other Name: Placebo Arm

Detailed Description:

Patients with ALL on Total XVI who experience NP/PN after specific doses of vincristine are eligible to enroll in the study as soon as the diagnosis of NP/PN related to VCR is established. The qualifying doses of vincristine have been selected because they fall in the schedule of weekly vincristine doses as per Total XVI, and 2 additional weekly vincristine doses are anticipated according to the protocol. Participants will be randomized to receive gabapentin or placebo upon enrollment. Morphine will be available to both groups as needed for pain at any time on the study. At the time of enrollment, and daily thereafter until completion of the study drug, data will be collected for pain assessment, and the daily dose of oral morphine used will be collected. Data regarding the pain type, quality, and location, as well as treatments used to manage pain will be assessed on a daily basis for the diagnostic event and for the period following the next two administrations of VCR treated with the study drug.

Primary Objective: To assess the analgesic efficacy of gabapentin in controlling VCR-related NP/PN in participants with ALL, by comparing the morphine daily dose (mg/kg/day) used to control NP/PN as a primary or a rescue regimen in the gabapentin vs. placebo groups.

Secondary Objective: To compare the pain scores in the gabapentin and placebo groups as recorded by pain score right now and pain score average for previous 24 hours.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is enrolled on Total XVI
  • Participant is 1 year of age or older
  • Participant has symptoms of NP/PN with onset no more than 7 days after one of the following vincristine doses: protocol week 1, week 2 (induction), week 7 (reinduction I), or week 17 (reinduction II).
  • Patient is expected to receive 2 doses of vincristine in weekly intervals as outlined by the Total XVI protocol while on study drug (i.e. no known dosage reductions or planned missed doses).

Participant is able and willing to take oral medications.

Exclusion Criteria:

  • Previous participation in this study
  • Participant is receiving gabapentin for another indication at the time of diagnosis of NP/PN or has received gabapentin previously.
  • Pregnancy. Female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days. Male patients with reproductive potential will be counseled not to procreate during the study.
  • Impaired renal function: decreased eGFR (<60ml/min/1.73m^2 as estimated by the revised Schwartz equation)
  • Participant has allergy or other contraindication for either morphine or gabapentin therapy.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506453

Contacts
Contact: Doralina Anghelescu, MD 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Doralina Anghelescu, MD    866-278-5833    info@stjude.org   
Principal Investigator: Doralina Anghelescu, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Doralina Anghelescu, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01506453     History of Changes
Other Study ID Numbers: TINALL
Study First Received: January 4, 2012
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Acute Lymphoblastic Leukemia
Neuropathy
Neuropathic Pain
Vincristine
TOTAL XVI Protocol

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Neuralgia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Gabapentin
Vincristine
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 22, 2014