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

NCT ID: NCT02808091

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early stage (IB or bulky disease - II)

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

Group Type: EXPERIMENTAL

GIFOX-Bortezomib

Intervention Type: DRUG

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

IMRT

Intervention Type: RADIATION

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

Advanced stage (III - IV)

will receive only chemotherapy alone

Group Type: EXPERIMENTAL

GIFOX-Bortezomib

Intervention Type: DRUG

GIFOX-Bortezomib will be given every 21 days for a total of 6 cycles.

Interventions

GIFOX-Bortezomib

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

Intervention Type: DRUG

GIFOX-Bortezomib

GIFOX-Bortezomib will be given every 21 days for a total of 6 cycles.

Intervention Type: DRUG

IMRT

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

Intervention Type: RADIATION

Other Intervention Names

Intensity-modulated radiation therapy

Eligibility Criteria

Inclusion Criteria

1. Extranodal NK/T-cell lymphomas

2. Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH.

3. Age more than or equals to 21 years.

4. Stages IB or bulky disease, II - IV

5. ECOG performance 0-2

6. 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.

7. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

1. 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).

2. History of peripheral neuropathy

3. HIV positive

4. Presence of CNS disease

5. Hypersensitivity to bortezomib, boron, or mannitol

6. Contraindication to any cytotoxic drug contained in the chemotherapy regimen.

7. 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.

8. 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.

9. Invasive or active malignancy in past 2 years.

10. Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soon Thye LIM

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

National Cancer Centre

Singapore, Singapore, Singapore

Countries

Singapore

Other Identifiers

NCC1004

Identifier Type: -

Identifier Source: org_study_id