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O(6)-Benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00003613   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: September 5, 2009   History of Changes

November 1, 1999
September 5, 2009
January 1999
 
Alkylguanine-DNA alkyltransferase (AGT) modulation as measured by skin biopsy at baseline, 6 and 24 hours, and 1 week after the start of study treatment [ Designated as safety issue: No ]
Alkylguanine-DNA alkyltransferase (AGT) modulation as measured by skin biopsy at baseline, 6 and 24 hours, and 1 week after the start of study treatment
Complete list of historical versions of study NCT00003613 on ClinicalTrials.gov Archive Site
 
 
 
O(6)-Benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
Phase I Trial of O6Benzylguanine and BCNU in Cutaneous T-Cell Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of carmustine given together with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment.

OBJECTIVES:

  • Determine the kinetics of O6-alkylguanine DNA alkyltransferase depletion in skin lesions of patients with cutaneous T-cell lymphoma after treatment with O6-benzylguanine.
  • Determine the toxicity of low-dose topical carmustine when administered after O6-benzylguanine in these patients.

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.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.

Phase I
Interventional
Treatment
Lymphoma
  • Drug: O6-benzylguanine
  • Drug: carmustine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
20
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed cutaneous T-cell lymphoma
  • Stage IA, IB, or IIA disease
  • Must be able to biopsy tumor
  • Must have failed 1 conventional treatment other than topical corticosteroids, including ultraviolet B light, psoralen ultraviolet light, topical mechlorethamine, electron beam, photophoresis, chemotherapy, or immunotherapy agents
  • No known CNS involvement or primary CNS malignancy

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT normal
  • Prothrombin time normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 70 mL/min

Metabolic:

  • Calcium and electrolytes normal
  • Glucose-controlled (diet and insulin) diabetes allowed

Pulmonary:

  • DLCO greater than 80% (except patients who demonstrate clinically normal lung function based on history, physical examination, and chest x-ray as determined by the principal investigator)
  • No pulmonary disease

Other:

  • No active infection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for two months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent hematopoietic growth factors

Chemotherapy:

  • See Disease Characteristics
  • No prior nitrosoureas

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Other:

  • At least 4 weeks since any prior therapy and recovered
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003613
 
CDR0000066690, CASE-CWRU-6496, NCI-T97-0029, CASE-6496
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Kevin Cooper, MD Ireland Cancer Center
Investigator: Stanton L. Gerson, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP