Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01073267
First received: February 19, 2010
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
The goal of this clinical research study is to learn if a lower than standard dose of total skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The safety of this dose level will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Radiation: TSEBT |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Objective Response Rate [ Time Frame: Baseline and at least 2 months ] [ Designated as safety issue: Yes ]Objective response rate defined as the proportion of patients achieving CCR and PR (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TSEBT
Total Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy
|
Radiation: TSEBT
Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
|
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Biopsy-confirmed mycosis fungoides in stage IB-IIIA
- Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
- 18 years of age or older
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) of </= 2
- Adequate bone marrow function: White blood count (WBC) >/= 2000/uL; platelet count>/= 100,000/mm3; Absolute neutrophil count (ANC) >/= 1000
- Required wash out period for prior therapies (Note: patients with progressive disease may be treated earlier than required washout period per Investigator's decision) a) Topical therapy: 2 weeks, b) Systemic biologic, monoclonal antibody or chemotherapy: 4 weeks, c) Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks, d) Other investigational therapy: 4 weeks
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
- Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
- Prior malignancy (active within 5 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix
- Pregnant or lactating
- Initiation or change in dosage of topical corticosteroids within 3 weeks of study treatment (Note: topical steroid use within 3 weeks is allowed provided the strength and use has been stable for at least 1 month; 'prescription strength' topical corticosteroids cannot be started during the study)
- Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073267
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Bouthaina Dabaja, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01073267 History of Changes |
| Other Study ID Numbers: | 2009-0444 |
| Study First Received: | February 19, 2010 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Stage IB-IIIA Mycosis fungoides Total Skin Electron Beam Therapy TSEBT |
Additional relevant MeSH terms:
|
Lymphoma Mycoses Mycosis Fungoides Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 16, 2013