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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.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003613
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: O6-benzylguanine
Drug: carmustine
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial of O6Benzylguanine and BCNU in Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: January 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003613

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Kevin Cooper, MD Case Comprehensive Cancer Center
Investigator: Stanton L. Gerson, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066690, CASE-CWRU-6496, NCI-T97-0029, CASE-6496
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003613     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome

Study placed in the following topic categories:
Immunoproliferative Disorders
Carmustine
Sezary Syndrome
Mycosis Fungoides
Recurrence
Lymphoma, Small Cleaved-cell, Diffuse
Mycoses
Lymphatic Diseases
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Carmustine
Enzyme Inhibitors
Sezary Syndrome
Mycosis Fungoides
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoma, T-Cell
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Alkylating Agents
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on September 02, 2009