Chemo + Radiation for Nasal NK Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Bouthaina S. Dabaja

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Hepatitis B, Hepatitis C, HIV, cardiovascular disease, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied. This is an investigational study. Radiation and chemotherapy are FDA approved and commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination of these therapies given at the same time is investigational. Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have pre-existing cardiovascular disease requiring ongoing treatment, you may not be eligible to participate.

What data supports the effectiveness of this treatment for nasal NK cell lymphoma?

Research shows that combining chemotherapy with radiation therapy can be effective for treating early-stage nasal NK/T-cell lymphoma, improving disease control and survival rates. Specifically, studies have found that concurrent chemoradiotherapy (using chemotherapy and radiation at the same time) can be beneficial for patients with this type of lymphoma. ^{1 2 3 4 5}

Is the combination of carboplatin, etoposide, ifosfamide, and radiation therapy generally safe for humans?

Studies have shown that the combination of carboplatin, etoposide, ifosfamide, and radiation therapy can be used safely in humans, although it may cause myelosuppression (a decrease in bone marrow activity leading to fewer blood cells) as a side effect. Other side effects like kidney and nerve damage were not observed in the studies. ^{6 7 8 9 10}

How is the treatment of Carboplatin, Etoposide phosphate, Ifosfamide, and Radiation Therapy unique for nasal NK cell lymphoma?

This treatment combines chemotherapy drugs like Carboplatin, Etoposide, and Ifosfamide with advanced radiation techniques such as intensity-modulated radiotherapy (IMRT), which allows precise targeting of the tumor while minimizing damage to surrounding healthy tissue. This approach is unique because it integrates both chemotherapy and radiation simultaneously, potentially enhancing effectiveness compared to using these treatments separately. ^{2 4 11 12 13}

Research Team

Bouthaina S. Dabaja

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with newly diagnosed stage I or II nasal NK cell lymphoma. Participants need normal blood counts, kidney and liver function, heart efficiency (ejection fraction ≥50%), and must not be pregnant or breastfeeding. They should agree to use contraception if of childbearing potential and have no active infections like Hepatitis B/C, HIV, severe heart conditions, or psychiatric issues that affect compliance.

Inclusion Criteria

Patients are required to have a serum creatinine </= 2.0 mg/dL (value obtained within two weeks before protocol entry)

Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%

I have been diagnosed with early-stage nasal NK cell lymphoma.

Exclusion Criteria

I do not have any active infections needing treatment.

I have a serious heart condition that needs ongoing treatment.

I've had radiation before where my cancer is now, and can't have more without risking harm.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy 5 days a week for 28 to 30 treatments

6 weeks

Weekly visits for physical exams and blood tests

Chemotherapy

Participants receive up to 3 cycles of chemotherapy, each cycle lasting 21 days

9 weeks

Visits on or before Day 1, Day 15 of Cycle 2, and Day 15 of Cycle 3 for blood tests and possible EKG

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 3 months for the 1st year, every 4 months during the 2nd year, every 6 months during the 3rd-5th years, then annually

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Dexamethasone (Corticosteroid)
• Etoposide phosphate (Topoisomerase Inhibitor)
• Ifosfamide (Alkylating agents)
• Mesna (Other)
• Radiation Therapy (Radiation)

Trial Overview The study tests the effectiveness of combining radiation therapy with chemotherapy drugs Etoposide phosphate, Ifosfamide, Carboplatin, Dexamethasone, and Mesna in controlling early-stage nasal NK cell lymphoma. The safety of this concurrent treatment approach is also being evaluated.

Participant Groups

Group I: Chemotherapy + Radiation Therapy Experimental Treatment 6 Interventions

Radiation therapy delivered for a total dose of 50.4 to 54 Gy over 28 to 30 treatments. Within seven days of starting radiotherapy, the first cycle of chemotherapy started and repeated every 3 weeks for a total of 3 cycles. DeVIC on day 1 of every cycle. Dexamethasone 40 mg by vein Days 1-3, Etoposide 67 mg/m2 by vein on Days 1-3, Ifosfamide 1 g/m2 by vein on Days 1-3, Mesna 0.4 g/m2 by vein on Days 1-3 with Ifosfamide, Mesna 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump, Carboplatin 200 mg/m2 by vein on Day 1. Cycles repeated every 21 days.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas MD Anderson Cancer Center Houston, TX

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

Findings from Research

In a study of 79 patients with early stage nasal NK/T-cell lymphoma, the overall complete response rate was 68.4%, but the long-term outcomes were poor, with only 35.5% disease-free survival and 37.9% overall survival at 5 years.

Adding anthracycline-containing chemotherapy to radiation therapy did not improve survival rates compared to radiation alone, indicating that radiation therapy remains the primary treatment for this type of lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early stage nasal NK/T-cell lymphoma: clinical outcome, prognostic factors, and the effect of treatment modality. Cheung, MM., Chan, JK., Lau, WH., et al.[2022]

In a phase II trial involving 30 patients with early-stage nasal NK/T-cell lymphoma, concurrent chemoradiotherapy (CCRT) resulted in a 100% response rate, with 73.3% achieving complete responses, indicating high efficacy of this treatment approach.

The treatment was well-tolerated, with only one patient experiencing significant nausea and a notable incidence of grade 4 neutropenia in 12 patients, while the estimated 3-year progression-free survival rate was 85.19%, suggesting a promising long-term outcome for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of concurrent radiation and weekly cisplatin followed by VIPD chemotherapy in newly diagnosed, stage IE to IIE, nasal, extranodal NK/T-Cell Lymphoma: Consortium for Improving Survival of Lymphoma study. Kim, SJ., Kim, K., Kim, BS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

First-Line Chemoradiation With or Without Chidamide (Tucidinostat) in Patients With Intermediate- and High-Risk Early-Stage Extranodal Nasal-Type Natural Killer/T-Cell Lymphoma: A Randomized Phase 2 Study in China. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Sequential chemotherapy followed by radiotherapy versus concurrent chemoradiotherapy in patients with stage I/II extranodal natural killer/T-cell lymphoma, nasal type. [2021]

3. China pubmed.ncbi.nlm.nih.gov

[Prognostic factors and treatment outcome in early stage nasal NK/T cell lymphoma]. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Concurrent Etoposide, Steroid, High-dose Ara-C and Platinum chemotherapy with radiation therapy in localised extranodal natural killer (NK)/T-cell lymphoma, nasal type. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Early stage nasal NK/T-cell lymphoma: clinical outcome, prognostic factors, and the effect of treatment modality. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Etoposide and cisplatin versus paclitaxel and carboplatin with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer: a multicenter randomized phase III trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Concurrent carboplatin, etoposide and thoracic radiation for poor-risk stage III non-small-cell lung carcinoma: a pilot study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Dose-finding studies with carboplatin, ifosfamide, etoposide, and mesna in non-small cell lung cancer. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Cisplatin, ifosfamide, oral etoposide, and concurrent accelerated hyperfractionated thoracic radiation for patients with limited small-cell lung carcinoma: results of radiation therapy oncology group trial 93-12. [2018]

10. China pubmed.ncbi.nlm.nih.gov

[A phase I clinical trial of combination chemotherapy of paclitaxel with carboplatin and concurrent radiation therapy in locally advanced non-small cell lung cancer]. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Mild toxicity and favorable prognosis of high-dose and extended involved-field intensity-modulated radiotherapy for patients with early-stage nasal NK/T-cell lymphoma. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of concurrent radiation and weekly cisplatin followed by VIPD chemotherapy in newly diagnosed, stage IE to IIE, nasal, extranodal NK/T-Cell Lymphoma: Consortium for Improving Survival of Lymphoma study. [2022]

13. China pubmed.ncbi.nlm.nih.gov

[Curative effect of nasal type extranodal NK/T-cell lymphoma by sequential chemotherapy combined radiotherapy compared with chemotherapy]. [2014]