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A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides


Phase 2
18 Years
N/A
Not Enrolling
Both
Mycosis Fungoides, Lymphomas: Non-Hodgkin, Lymphomas: Non-Hodgkin Peripheral T-Cell, Lymphomas: Non-Hodgkin Cutaneous Lymphoma

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Trial Information

A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides


Inclusion Criteria:

1. Biopsy-confirmed mycosis fungoides in stage IB-IIIA

2. Patients must have failed or have been intolerant to at least one prior systemic or
topical therapy which may include topical steroids

3. 18 years of age or older

4. Life expectancy greater than 6 months

5. Eastern Cooperative Oncology Group (ECOG) of <= 2

6. Adequate bone marrow function: WBC> 2000/uL; platelet count> 75,000/mm3; ANC> 1000

7. Required wash out period for prior therapies (Note: patients with progressive disease
may be treated earlier than required washout period per Investigator's decision)

- Topical therapy: 2 weeks

- Systemic biologic, monoclonal antibody or chemotherapy: 4 weeks

- Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks

- Other investigational therapy: 4 weeks

8. Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:1. Prior courses of TSEBT (Note: localized skin-directed radiotherapy
is allowed if administered at least 4 weeks prior to initiation on study)

2. Underlying medical condition including unstable cardiac disease, or other serious
illness that would impair the ability of patient to undergo treatment

3. 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

4. Pregnant or lactating

5. 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)

6. Any other medical history, including laboratory results, deemed by the Investigator to
be likely to interfere with patient participation in the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray (TSEBT 12 Gy) in patients who have mycosis fungoides (MF) staged as IB to IIIA. Outcome Time Frame:

Outcome Time Frame:

monthly

Safety Issue:

Yes

Principal Investigator

Richard T. Hoppe

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

LYMNHL0072

NCT ID:

NCT00985140

Start Date:

June 2009

Completion Date:

December 2015

Related Keywords:

  • Mycosis Fungoides
  • Lymphomas: Non-Hodgkin
  • Lymphomas: Non-Hodgkin Peripheral T-Cell
  • Lymphomas: Non-Hodgkin Cutaneous Lymphoma
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides

Name

Location

Stanford University School of MedicineStanford, California  94305-5317