Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma


Phase 1
19 Years
N/A
Not Enrolling
Both
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma

Thank you

Trial Information

Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma


PRIMARY OBJECTIVES:

I. To determine the kinetics of AGT depletion in CTCL skin lesions. II. To determine the
toxicity of low dose BCNU plus O6BG.

OUTLINE: This is a dose-escalation study of carmustine.

Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2
weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.

Patients are followed for 6 weeks.


Inclusion Criteria:



- Histologically confirmed CTCL, stages IA-IIA

- Performance status ECOG grade 0, 1, or 2

- Patients must have recovered from toxicity of prior treatment and have received no
CTCL therapy other than emoliation for at least 4 weeks

- Patients must have signed a consent form indicating the investigational nature of the
treatment and its potential side effects

- WBC > 4,000/ul

- ANC > 2,000/ul

- Platelets > 100,000/ul

- Bilirubin < 1.5 mg/dL

- SGOT within normal range

- Prothrombin time within normal range

- Creatinine =< 1.5 mg/dL or creatinine clearance >= 70 ml/min

- Calcium and electrolytes normal

- Glucose-controlled (diet and insulin) diabetes is permitted

- DLCO > 80% normal with the exception of patients who demonstrate clinically normal
lung function based on history, physical examination, and chest x-ray as interpreted
by the principal investigator

- Only those patients with biopsiable tumor and willing to undergo several biopsies
will be eligible

- Must have failed 1 conventional treatment other than topical corticosteroids; this
includes UVB, PUVA, topical mechlorethamine, electron beam, photopheresis,
chemotherapy and immuno-modulatory agents such as cytokines

Exclusion Criteria:

- Patients with a prior treatment with a nitrosourea

- Patients with known central nervous system involvement or primary CNS malignancies
will be ineligible

- Patients with performance status ECOG grade 3 or 4

- Pregnant women, women who are breast feeding infants, or women with reproductive
potential not practicing adequate contraception, because of potential toxicity to the
fetus or infant

- Patients with active infection

- Patients with pulmonary disease as determined by history, physical examination, chest
X-ray or pulse oximetry

- CTCL patients with stage IIB-IVB disease

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent decrease of AGT in CTCL skin lesions, obtained from tissue samples

Outcome Description:

Point and interval estimates of response using the binomial distribution will be obtained using data from patients with measurable or evaluable disease. If responses occur, then the mean and median duration of response will be determined. Statistical significance will be determined using the t test for analysis of continuous data.

Outcome Time Frame:

Baseline to 6 weeks

Safety Issue:

No

Principal Investigator

Kevin Cooper

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03119

NCT ID:

NCT00003613

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location
Case Western Reserve University Cleveland, Ohio  44106