O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma

NCT00003613 | Terminated Phase 1

• 3 other identifiers: NCI-2012-03119CWRU 6496U01CA062502
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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

Conditions

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline to 6 weeks

• MTD of carmustine estimated as the dose level which is one level below where >= 2 DLT are observed

  Toxicities will be recorded and tabulated. Additional point and interval estimates for the MTD will be obtained using the methods of logistic regression of the proportion of patients experiencing a dose-limiting toxicity of grade \>= 2 and by conventional regression of the mean dose-limiting toxicities on dose level.

  6 weeks

Study Arms (1)

Treatment (O6-benzylguanine, carmustine)

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.

Drug: O6-benzylguanine; Drug: carmustine; Other: laboratory biomarker analysis

Interventions

O6-benzylguanine DRUG

Given IV

Also known as: BG

Treatment (O6-benzylguanine, carmustine)

carmustine DRUG

Given topically

Also known as: BCNU, BiCNU, bis-chloronitrosourea

Treatment (O6-benzylguanine, carmustine)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (O6-benzylguanine, carmustine)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Apisarnthanarax N, Wood GS, Stevens SR, Carlson S, Chan DV, Liu L, Szabo SK, Fu P, Gilliam AC, Gerson SL, Remick SC, Cooper KD. Phase I clinical trial of O6-benzylguanine and topical carmustine in the treatment of cutaneous T-cell lymphoma, mycosis fungoides type. Arch Dermatol. 2012 May;148(5):613-20. doi: 10.1001/archdermatol.2011.2797.

  PMID: 22250189 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

O(6)-benzylguanine; Carmustine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Kevin Cooper

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1999
• Primary Completion: May 1, 2006
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

US (1)