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

NCT01506453 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: TINALLNCI-2012-00413
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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 (or for those being treated "as per TOTXVI 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.

Conditions

Acute Lymphoblastic Leukemia; Neuropathy; Neuropathic Pain

Keywords

Acute Lymphoblastic Leukemia; Neuropathy; Neuropathic Pain; Vincristine; TOTAL XVI Protocol

Outcome Measures

Primary Outcomes (1)

• Daily Total Dose of Oral Morphine (mg/kg/Day).

  The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar.

  Daily beginning day 1 for a maximum of 21 days.

Secondary Outcomes (2)

• Pain Scores Right Now

  Daily beginning day 1 through a maximum of 21 days.

• Pain Score During the Previous 24 Hours

  Daily beginning day 1 through a maximum of 21 days

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Active treatment arm.

Drug: gabapentin

Placebo

PLACEBO COMPARATOR

Placebo arm.

Drug: placebo

Interventions

gabapentin DRUG

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.

Also known as: Treatment Arm

Gabapentin

placebo DRUG

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.

Also known as: Placebo Arm

Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant is enrolled on Total XVI or who are being treated "as per TOTXVI protocol"
• 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 ± 3 days: 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 (or for those being treated "as per TOTXVI" protocol) while on study drug (i.e. no known dosage reductions or planned missed doses).
• Participant is able and willing to take oral medications.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neuralgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Doralina Anghelescu, MD
• Organization: St. Jude Children's Research Hospital

doralina.anghelescu@stjude.org

(901) 595-4034

Study Officials

• Doralina Anghelescu, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 10, 2012
• Study Start: January 24, 2012
• Primary Completion: January 2, 2018
• Study Completion: January 2, 2018
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-04

Locations

US (1)