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A Pilot Study of Short (1-2.5 h), Medium (4-6 h) and Long (18-24 h) Applications of 20% Topical ALA-PDT for Photodynamic Therapy of Cutaneous T and B Cell Lymphomas and Cutaneous Infiltrates of Early CLL


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

A Pilot Study of Short (1-2.5 h), Medium (4-6 h) and Long (18-24 h) Applications of 20% Topical ALA-PDT for Photodynamic Therapy of Cutaneous T and B Cell Lymphomas and Cutaneous Infiltrates of Early CLL


OBJECTIVES:

- Determine the pain grade and epidermal toxic response (ETR) of patients with T-cell or
B-cell lymphoma or early chronic lymphocytic leukemia with cutaneous infiltrates
treated with photodynamic therapy using aminolevulinic acid.

- Determine the feasibility of maintaining a pain grade of 1 or less and an approximate
ETR of 2 in patients receiving up to 12 sessions of this regimen.

- Determine the maximal irradiance and corresponding exposure among multiple treatments
at the same site and among different sites in the same and in different patients.

- Determine the cumulative response achieved at the completion of treatment in these
patients.

- Determine the number of sessions required to complete treatment in these patients.

- Correlate ETR with incremental treatment response in patients treated with this
regimen.

OUTLINE: This is a randomized study. Patients' individual lesions are randomized to 1 of 3
treatment arms.

- Arm I: Patients receive a short duration of topical aminolevulinic acid (ALA) on the
lesion and surrounding normal skin. The lesion is then illuminated with red light for
up to 30 minutes.

- Arm II: Patients receive a medium duration of ALA followed by light illumination as in
arm I.

- Arm III: Patients receive a long duration of ALA followed by light illumination as in
arm I.

In all arms, treatment repeats every 2 weeks for up to 12 courses in the absence of
unacceptable toxicity or progressive (systemic) disease.

Additional patients are accrued to a treatment arm if at least 2 of 3 patients on that arm
experience 25% cumulative clinical response.

Patients are followed at 1, 3, and 6 months and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 4-10 patients will be accrued for this study within 5-7 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following histologically confirmed diagnoses:

- Cutaneous B-cell or T-cell lymphoma confined to the skin

- No evidence of internal disease other than peripheral adenopathy

- Early chronic lymphocytic leukemia with cutaneous B-cell infiltrates not
requiring systemic therapy

- Stable or slowly progressive disease that is not expected to substantially change
during treatment

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- No porphyria or known hypersensitivity to porphyrins

- No known photosensitivity diseases

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Concurrent clinically necessary interferon alfa allowed

Chemotherapy

- No concurrent systemic multiagent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent local radiotherapy to study lesions

- No concurrent whole body radiotherapy

Surgery

- Not specified

Other

- More than 1 month since prior topical therapy to study lesions

- Concurrent topical therapy to non-study lesions allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Pain grade and epidermal toxic response (ETR)

Safety Issue:

Yes

Principal Investigator

Allan R. Oseroff, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

DS 97-32

NCT ID:

NCT00054171

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • B-cell chronic lymphocytic leukemia
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage I mycosis fungoides/Sezary syndrome
  • stage 0 chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263