Combining chemotherapy and radiation for nasal NK cell lymphoma
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
This study is testing if combining chemotherapy and radiation can help people with newly diagnosed nasal NK cell lymphoma feel better and control their cancer more effectively than standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02106988 on ClinicalTrials.gov |
What this trial studies
This clinical research focuses on evaluating the effectiveness and safety of concurrent chemotherapy and radiation therapy for patients with newly diagnosed Stage 1 and/or 2 nasal NK cell lymphoma. Participants will receive radiation therapy five days a week for up to six weeks, along with up to three cycles of chemotherapy that includes dexamethasone, etoposide, ifosfamide, and carboplatin. The study aims to determine if this combination treatment can better control the lymphoma compared to standard approaches. Regular assessments will be conducted to monitor patient health and treatment response throughout the study.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed Stage 1 and II nasal NK cell lymphoma who meet specific health criteria.
Not a fit: Patients with advanced-stage NK cell lymphoma or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with nasal NK cell lymphoma.
How similar studies have performed: While the combination of these therapies is investigational, previous studies have shown promise in treating similar conditions with concurrent chemotherapy and radiation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with newly diagnosed stage I and II nasal NK cell lymphoma. 2. Adequate blood cell counts (i.e. ANC \> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin. 3. Patients must have adequate liver function as indicated by: \*Bilirubin \</= 1.5 times the upper limit of normal (ULN), \* Alanine transaminase (ALT) \</= 2 times the (ULN) or aspartate transaminase (AST) \</= 2 times the ULN, \*These values must be obtained within two weeks before protocol entry. 4. Patients are required to have a serum creatinine \</= 2.0 mg/dL. This value must be obtained within two weeks before protocol entry. 5. Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure \>/= 50%. 6. Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study. 7. Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses \> two years or surgically sterilized). 8. Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry. 9. Patients must have the ability to give informed consent. Exclusion Criteria: 1. Patients with active Hepatitis B and/or Hepatitis C infection. 2. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved. 3. Patients known to be HIV positive. 4. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a) Congestive heart failure class III/IV CHF per new york heart association (NYHA) criteria. b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d) Unstable angina pectoris, e) Recent MI (within 6 months). 5. Patients who are pregnant or breast-feeding. 6. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements. 7. Prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Bouthaina Dabaja, MD — M.D. Anderson Cancer Center
- Study coordinator: Bouthaina Dabaja, MD
- Email: bdabaja@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.