Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma

NCT02808091 | Terminated Phase 2

• 1 other identifier: NCC1004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

• Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV.
• Assess the toxicity and maximum tolerated dose of bortezomib administered in combination with GIFOX chemotherapy.

Conditions

Extranodal NK-T-CELL LYMPHOMA

Outcome Measures

Primary Outcomes (1)

• Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT)

  Assess the response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy together with intensity-modulated radiation therapy (IMRT) in stage IB or bulky disease - II patients and chemotherapy alone in stage III - IV patients.

  3 years

Secondary Outcomes (3)

• Progression free survival (PFS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients

  3 years

• Overall survival (OS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients

  5 years

• Toxicity of bortezomib administered in combination with GIFOX chemotherapy

  3 years

Study Arms (2)

Early stage (IB or bulky disease - II)

EXPERIMENTAL

who will receive GIFOX-B chemotherapy followed by involved field radiotherapy.

Drug: GIFOX-Bortezomib; Radiation: IMRT

Advanced stage (III - IV)

EXPERIMENTAL

will receive only chemotherapy alone

Drug: GIFOX-Bortezomib

Interventions

GIFOX-Bortezomib DRUG

GIFOX-Bortezomib will be given every 21 days for 4 cycles

Early stage (IB or bulky disease - II)

IMRT RADIATION

a minimum of 50 Gy of IMRT to tumor bed and neck (5 weeks)

Also known as: Intensity-modulated radiation therapy

Early stage (IB or bulky disease - II)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Extranodal NK/T-cell lymphomas
• Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH.
• Age more than or equals to 21 years.
• Stages IB or bulky disease, II - IV
• ECOG performance 0-2
• Laboratory tests: ANC more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3. Creatinine less than or equals to 2x ULN or creatinine clearance more than or equals to 50 ml/min; AST and ALT less than or equals to 3x ULN. Total bilirubin \< 1.5x ULN except \< 3x ULN in patients with Gilbert's (as defined as \> 80% unconjugated hyperbilirubinemia without other known cause); unless impairment is due to organ involvement by lymphoma.
• Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

• Had prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome).
• History of peripheral neuropathy
• HIV positive
• Presence of CNS disease
• Hypersensitivity to bortezomib, boron, or mannitol
• Contraindication to any cytotoxic drug contained in the chemotherapy regimen.
• Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion.
• Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential.
• Invasive or active malignancy in past 2 years.
• Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre

Singapore, Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Soon Thye LIM

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 21, 2016
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

SG (1)