Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Indolent B Cell Lymphoma

Orbital Lymphoma

Patients undergo two fractions of low dose orbital EBRT on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.

External Beam Radiation Therapy

Participants receive radiation to entire involved orbit for a total dose of 4 Gy in 2 fractions over two consecutive days with external beam radiotherapy. If there is stable disease or progressive disease, an additional 20 Gy administered to involved site. If there are two consecutive evaluations with no change in disease burden then an additional 20 Gy administered. At one year if there is persistent disease, an additional 20 Gy administered to involved site.

Orbital Radiation

Chelsea C Pinnix, M D

This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Orbital radiation therapy uses external beam radiation to destroy cancer cells. Using ultra low dose orbital radiation therapy may be effective in treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye and may have fewer side effects.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of ultra low dose 4 Gray (Gy) orbital radiation, measured as local orbital control (i.e. local control within the radiation field), in patients with limited and advanced stage low grade B lymphocyte (B cell) lymphoma and mantle cell lymphoma involving the ocular adnexa.

II. To evaluate the efficacy of ultra low dose 4 Gy orbital radiation, measured as complete response, in patients with limited and advanced stage low grade B cell lymphoma and mantle cell lymphoma involving the ocular adnexa.

III. To evaluate the acute and chronic toxicity of radiation to the orbit.

SECONDARY OBJECTIVE:

I. To determine if dynamic contrast enhanced magnetic resonance imaging can predict response to ultra low dose radiation therapy.

OUTLINE:

Patients undergo low dose orbital external beam radiation therapy (EBRT) on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.

After completion of study treatment, patients are followed up every 3-4 months for 6-8 months, every 6-12 months for up to 2 years, and then periodically thereafter.

Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma

Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma

Local orbital event will be estimated using the Kaplan-Meier method.

Response rate will be estimated along with 95% confidence intervals.

OS will be estimated using the Kaplan-Meier method.

Toxicity data will be summarized by frequency tables.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Recurrence

Kennedy Disease

All Drugs and Chemicals

Androgens

Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.

Enzalutamide

Laboratory Biomarker Analysis

Ajay Gopal

This pilot clinical trial studies enzalutamide in treating patients with mantle cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Androgens can cause the growth of cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgen made by the body.

PRIMARY OBJECTIVES:

I. Perform a preliminary assessment of the efficacy of single-agent enzalutamide, based on overall response rate, in subjects with relapsed/refractory mantle cell lymphoma (MCL) or previously untreated MCL.

SECONDARY OBJECTIVES:

I. To evaluate the duration of disease control (progression free survival) in patients with MCL treated with enzalutamide.

II. To evaluate the safety profile of enzalutamide in MCL.

III. To gain preliminary data on clinical activity and toxicity of this regimen in male versus (vs.) female patients.

OUTLINE:

Patients receive enzalutamide orally (PO) once daily (QD). Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 5 years.

Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Androgen Receptor Targeting in Mantle Cell Lymphoma: A Pilot Trial of Enzalutamide

An ORR of 20% (4 or more responses among 20 patients) will be taken as a benchmark for success for the primary endpoint of this pilot study. Evaluation of response is per standard NCI Response Criteria Cheson 2014 and assessed by PET-CT; CR = complete metabolic response, PR = decrease by more the 50% in the sum of the product of the perpendicular diameters.

Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).

The count of participants who achieved a CR, PR, or SD for greater than 3 months.

National Comprehensive Cancer Network

University of Washington

Professor, Department of Medicine, Division of Oncology; Director, Hematologic Malignancies Medical Oncology

Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.

Enzalutamide: Given PO

Laboratory Biomarker Analysis: Correlative studies

Treatment (Enzalutamide)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Ajay K. Gopal, MD

Best Overall Response Rate (ORR) Including Complete Response (CR) and Partial Response (PR) as Measured by Standard Criteria

Time to Treatment Failure

Progression-free Survival

Overall Survival

Number of Participants With One or More Adverse Events, Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma	NCT02494700	Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ocular Adnexal ... Ocular Adnexal ... Orbit Lymphoma	External Beam R... Orbital Radiati...	18 Years -	M.D. Anderson Cancer Center
Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma	NCT02489123	Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Ann Arbor Stage... Recurrent Mantl... Refractory Mant...	Enzalutamide Laboratory Biom...	18 Years -	University of Washington

Spots Global Cancer Trial Database for ann arbor stage i mantle cell lymphoma