Suspended

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

What is being tested

O6-benzylguanine

+ carmustine

+ laboratory biomarker analysis

DrugOther

Who is being recruted

Hemic and Lymphatic Diseases+8

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 19 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: April 1999

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)

Last updated: January 11, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003613

Principal SponsorNational Cancer Institute (NCI)

Last updated: January 11, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, T-CellLymphoma, T-Cell, Cutaneous

Criteria

16 inclusion criteria required to participate

ANC > 2,000/ul

Bilirubin < 1.5 mg/dL

Calcium and electrolytes normal

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

Show More Criteria

7 exclusion criteria prevent from participating

CTCL patients with stage IIB-IVB disease

Patients with a prior treatment with a nitrosourea

Patients with active infection

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Case Western Reserve University

Cleveland, United StatesOpen Case Western Reserve University in Google Maps

SuspendedOne Study Center