A Phase 1/2 interventional study of Radiation and Cyclophosphamide in Lymphoma, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-05.
Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Treatment
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 radiation and chemotherapy will also be studied.
The Study Treatments:
Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.
CHOP chemotherapy is made up of the drugs cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), and prednisone. It is designed to help control the tumor locally as well as the tumor cells that might have escaped and moved through the body.
Radiation Therapy:
You will receive radiation therapy 5 days a week for 28 to 30 treatments. You will receive a separate consent form that will describe this procedure and its risks in more detail.
Study Visits During Radiation Therapy:
Every week for 6 weeks during radiation therapy:
Chemotherapy Administration:
The amount of time after you finish radiation therapy before you can begin receiving chemotherapy will depend on your recovery time and any side effects you may have. This should be about 3-4 weeks.
On Day 1 you will receive cyclophosphamide by vein over 1 hour, doxorubicin by vein over 15 minutes, and vincristine by vein over 15 minutes. You will take prednisone by mouth on Days 1-5 of each cycle. Each cycle will be 21-days long (or longer if it takes longer for your blood counts to recover). You will receive up to 4 cycles of chemotherapy.
Study Visits During Chemotherapy:
Before Day 1 of Cycle 1:
On Day 15 of Cycle 1:
On Day 1 of Cycles 2-4:
On Day 15 of Cycles 2-4:
-Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Study:
You may receive radiation and up to 4 cycles of CHOP. You will no longer be able to receive CHOP if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over after the end-of-study and follow-up visits.
Follow-Up and End-of-Study Visits:
If you leave the study early:
Routine Follow-up:
Up to 40 patients will take part in this study. All will be enrolled at University of Texas (UT) MD Anderson Cancer Center.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
Radiation: Radiation · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone
50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments.
Also known as: XRT, Radiation therapy
750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.
Also known as: Cytoxan, Neosar
50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.
Also known as: Adriamycin, Rubex
1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle.
Also known as: Oncovin
100 mg by mouth daily on Days 1-5 of a 21 day cycle.
Progression-free Survival (PFS)
Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.
Time frame: Day 1 to disease progression or death (up to 5+ years)
Recruitment Period: May 20, 2011 to May 8, 2013. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
| Milestone | Radiation + Chemotherapy |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Early study termination | 1 |
Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.
No measurements were reported for this outcome.
Collected over Adverse Event (AE) monitoring during study participation from baseline to completion of 4 cycles, each 21 days. Serious AEs monitored until resolved or clearly determined to be due to stable or chronic condition or intercurrent illness(es).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiation + Chemotherapy | — | 0/1 (0%) | 1/1 (100%) |
| Event | Radiation + Chemotherapy |
|---|---|
| Erythema MultiformeSkin and subcutaneous tissue disorders | 1/1 |
| Sinus DisorderInfections and infestations | 1/1 |
| FatigueGeneral disorders | 1/1 |
| Respiratory, Thoracic and Mediastinal DisordersRespiratory, thoracic and mediastinal disorders | 1/1 |
| Age, Categorical(Participants) | Radiation + Chemotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Radiation + Chemotherapy |
|---|---|
| Female | 0 |
| Male | 1 |
| Region of Enrollment(participants) | Radiation + Chemotherapy |
|---|---|
| United States | 1 |
This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center